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bimatoprost

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Description

Bimatoprost: A cloprostenol-derived amide that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5311027
CHEMBL ID1200963
CHEBI ID51230
SCHEMBL ID24425
MeSH IDM0395184

Synonyms (76)

Synonym
CHEBI:51230 ,
(5z)-7-{(1r,2r,3r,5s)-3,5-dihydroxy-2-[(1e,3s)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl}-n-ethylhept-5-enamide
bimatoprostum
gtpl1958
LS-181817 ,
latisse
5-heptenamide, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-, (1r-1(alpha(z),2beta(1e,3s*)3alpha,5alpha))-
5-heptenamide, 7-(3,5-dihydroxy-2-(3-hydrdoxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-, (1r-(1alpha(z),2beta(1e,3s*),3alpha,5alpha))-
lumigan
agn 192024
(z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((1e,3s)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-5-heptenamide
agn-192024
5-heptenamide, 7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((1e,3s)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-, (5z)-
latisse (tn)
D02724
lumigan (tn)
155206-00-1
bimatoprost (jan/usan/inn)
15m ,
(5z)-7-{(1r,2r,3r,5s)-3,5-dihydroxy-2-[(1e,3s)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl}-n-ethylhept-5-enamide
NCGC00181745-01
bimatoprost
DB00905
CHEMBL1200963
prostamide
(z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(e,3s)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl]-n-ethylhept-5-enamide
qxs94885mz ,
unii-qxs94885mz
bimatoprost [usan:inn:ban:jan]
AKOS015995566
bimatoprost [inci]
bimatoprost [ema epar]
bimatoprost [mart.]
bimatoprost component of ganfort
ganfort component bimatoprost
bimatoprost [vandf]
(z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(1e,3s)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-n-ethyl-5-heptenamide
bimatoprost [usan]
bimatoprost [inn]
bimatoprost [who-dd]
5-heptenamide, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-, (1r-1(.alpha.(z),2.beta.(1e,3s*)3.alpha.,5.alpha.))-
bimatoprost [mi]
bimatoprost [jan]
bimatoprost [orange book]
durysta
AM84507
HY-B0191
17-phenyl trinor prostaglandin f2alpha ethyl amide
smr000058996
MLS006010039
SCHEMBL24425
AQOKCDNYWBIDND-FTOWTWDKSA-N
FD10460
(5z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(1e,3s)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl]-n-ethylhept-5-enamide
SR-01000942224-1
sr-01000942224
mfcd03411999
17-phenyl-tri-norprostaglandin f2alpha-ethyl amide, >=95%, solid
us9271961, bimatoprost
bdbm220120
EX-A1769
DTXSID30895042 ,
AS-35082
Q2393348
5-heptenamide, 7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(1e,3s)-3-hydroxy-5-phenyl-1-penten-1-yl]cyclopentyl]-n-ethyl-, (5z)-
NCGC00181745-03
(5z)-bimatoprost
(e)-7-[3,5-dihydroxy-2-[(e)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl]-n-ethylhept-5-enamide
EN300-21680860
bimatoprost in bulk
B6165
bimatoprost (mart.)
5-heptenamide, 7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((1e,3s)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-n-ethyl-,(5z)-
s01ee03
dtxcid401324598
(5z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((1e,3s)-3-hydroxy-5-phenylpent-1-en-1-yl)cyclopentyl)-n-ethylhept-5-enamide

Research Excerpts

Overview

Bimatoprost is an intraocular pressure (IOP) lowering prostaglandin analog with different adverse side effects such as potential ocular inflammatory effect and ocular hyperemia. It is often used for eyelash growth for cosmetic reasons as well as in the treatment of glaucoma.

ExcerptReferenceRelevance
"Bimatoprost is a synthetic prostaglandin structural analogue used among other indications to increase eyelash growth. "( Topical bimatoprost in the treatment of eyelash loss in alopecia totalis and universalis: A prospective, open-label study.
Cetkovska, P; Hordinsky, M; Ricar, J; Ricarova, R, 2022
)
2.6
"Bimatoprost is a synthetic prostamide F"( Bimatoprost promotes satiety and attenuates body weight gain in rats fed standard or obesity-promoting diets.
Chuang, CL; Loomes, K; Poloso, NJ; Raymond, I; Spada, C; Tong, W; Vu, C; Walker, C; Woodward, DF, 2022
)
3.61
"Bimatoprost 0.03% is an intraocular pressure (IOP) lowering prostaglandin analog with different adverse side effects such as potential ocular inflammatory effect and ocular hyperemia."( Granulomatous uveitis and choroidal detachment in a patient after topical treatment with Bimatoprost: A case report.
Anna, F; Bordinone, MA; Massimo, L; Micelli Ferrari, L; MicelliFerrari, T; Nikolopoulou Gisotti, E; Zito, R, 2022
)
2.39
"Bimatoprost is an ophthalmic prostamide analog that is approved by the United States Food and Drug Administration for the treatment of eyelash hypotrichosis."( Therapeutic potential of bimatoprost for the treatment of eyebrow hypotrichosis.
Chanasumon, N; Sriphojanart, T; Suchonwanit, P, 2018
)
1.51
"Bimatoprost is a prostaglandin F2α analog and is often used for eyelash growth for cosmetic reasons as well as in the treatment of glaucoma."( Open-label pilot study to evaluate the effectiveness of topical bimatoprost on rhododendrol-induced refractory leukoderma.
Fukaya, S; Fukuyasu, A; Hayashi, K; Iimuro, S; Ishikawa, T; Kamata, M; Kasanuki, T; Ohnishi, T; Tada, Y; Takeoka, S; Tanaka, T; Watanabe, S; Yokobori, M, 2018
)
1.44
"Bimatoprost is a prostaglandin analogue used topically in the treatment of glaucoma. "( Bimatoprost (0.03%)-induced accommodative spasm and pseudomyopia.
Padhy, D; Rao, A, 2015
)
3.3
"Bimatoprost is a potent hypotensive drug used in the treatment of glaucoma or ocular hypertension with lower target intraocular pressure (IOP) than latanoprost. "( Incidence of hyperemia associated with bimatoprost treatment in naïve subjects and in subjects previously treated with latanoprost.
Kurtz, S; Mann, O,
)
1.84
"Bimatoprost is a synthetic prostamide analog that is efficacious in the treatment of open-angle glaucoma, ocular hypertension and other forms of glaucoma. "( Bimatoprost - a review.
Edward, DP; Patil, AJ; Vajaranant, TS, 2009
)
3.24
"Bimatoprost is a neutral lipid, a fatty acid amide that pharmacologically acts in both its paternal amide form and through its hydrolysis product (active free fatty acid of bimatoprost). "( [Bimatoprost therapy in glaucoma].
Călugăru, D; Călugăru, M, 2009
)
2.71
"Bimatoprost (Lumigan) is a synthetic prostamide that reduces intraocular pressure (IOP) by increasing the outflow of aqueous humour. "( Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension.
Curran, MP, 2009
)
3.24
"Bimatoprost is a widely used ocular hypotensive agent to treat glaucoma. "( Cellular basis for bimatoprost effects on human conventional outflow.
Carling, RW; Cornell, CL; Fliri, H; Jolas, T; Martos, J; Pettit, SN; Piwnica, D; Stamer, WD; Wang, JW; Woodward, DF, 2010
)
2.13
"Bimatoprost appears to be a valuable new agent for glaucoma therapy."( An update on bimatoprost in glaucoma therapy.
Cantor, LB, 2002
)
1.41
"Bimatoprost is a synthetic prostamide, chemically related to prostamide F. "( Granulomatous anterior uveitis associated with bimatoprost: a case report.
Parentin, F, 2003
)
2.02
"Bimatoprost is a pharmacologically unique and highly efficacious anti-glaucoma agent. "( Update on the mechanism of action of bimatoprost: a review and discussion of new evidence.
Krauss, AH; Woodward, DF, 2004
)
2.04
"Bimatoprost is a structural analog of PGF2alpha-ethanolamide (prostamide F2alpha), which is formed from the endocannabinoid anandamide by a biosynthetic pathway involving cyclooxygenase-2 (COX-2)."( Bimatoprost: a novel antiglaucoma agent.
Chen, J; Krauss, AH; Liang, Y; Phelps, RL; Short, B; Weber, A; Wheeler, LA; Woodward, DF, 2004
)
2.49
"Bimatoprost is a synthetic analog of prostaglandin F(2 alpha) ethanolamide (prostamide F(2 alpha)), and shares a pharmacological profile consistent with that of the prostamides. "( Bimatoprost and prostaglandin F(2 alpha) selectively stimulate intracellular calcium signaling in different cat iris sphincter cells.
Chen, J; Krauss, AH; Nieves, AL; Protzman, CE; Sachs, G; Scott, DF; Spada, CS; Wheeler, LA; Woodward, DF, 2005
)
3.21
"Bimatoprost is an effective alternative to topical beta-blockers for the treatment of glaucoma and ocular hypertension."( The efficacy of bimatoprost 0.03% monotherapy in patients previously using topical beta-blocker monotherapy for the treatment of glaucoma or ocular hypertension.
Earl, ML; Quinones, R,
)
1.2
"Bimatoprost is a safe and well-tolerated intraocular pressure (IOP) lowering drug that was approved in the United States in 2001 for the treatment of glaucoma and ocular hypertension. "( Bimatoprost: mechanism of ocular surface hyperemia associated with topical therapy.
Chen, J; Dinh, T; Holland, M; Lin, TH; Wheeler, LA; Woodward, DF; Yuan, YD, 2005
)
3.21
"Bimatoprost (BMP), which is a highly effective ocular hypotensive agent, is a PGF(2)(alpha) analogue that inhibits both the PGD(2) 11-ketoreductase and PGH(2) 9,11-endoperoxide reductase activities of PGFS."( Prostaglandin F2alpha formation from prostaglandin H2 by prostaglandin F synthase (PGFS): crystal structure of PGFS containing bimatoprost.
Komoto, J; Takusagawa, F; Watanabe, K; Woodward, DF; Yamada, T, 2006
)
1.26
"Bimatoprost (Lumigan) is a prostamide analogue used for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. "( Bimatoprost: a pharmacoeconomic review of its use in open-angle glaucoma and ocular hypertension.
Keam, SJ; Plosker, GL, 2006
)
3.22
"Bimatoprost is a structural analog of prostaglandin F2 alpha-ethanolamide (PGF2a), a class of compounds that in systemic form has been associated with alterations in serum lipid levels."( Decreased high-density lipoprotein serum levels associated with topical bimatoprost therapy.
Steinhäuser, SL, 2006
)
1.29
"Bimatoprost is a synthetic molecule that is structurally and pharmacologically similar to prostamide F(2), and appears to mimic the activity of the prostamides."( Clinical pharmacology of bimatoprost.
Cantor, LB, 2005
)
1.35
"Bimatoprost (Lumigan) is a pharmacologically unique and highly efficacious ocular hypotensive agent. "( The pharmacology of bimatoprost (Lumigan).
Andrews, SW; Archeampong, A; Brar, B; Burk, RM; Chen, J; Chen, R; Garst, ME; Gil, DW; Kaplan, LJ; Kedzie, KM; Kharlamb, A; Krauss, AH; Lai, RK; Liang, Y; Ling, J; Madhu, C; Ni, J; Rix, P; Shi, L; Spada, CS; Tang-Liu, DD; Usansky, H; Usansky, J; Weber, A; Welty, D; Wheeler, LA; Woodward, DF; Yang, W, 2001
)
2.08
"Bimatoprost is a new ocular hypotensive agent that lowers intraocular pressure (IOP) in normal, ocular hypertensive, and glaucomatous eyes. "( Mechanism of action of bimatoprost (Lumigan).
Brubaker, RF, 2001
)
2.06

Effects

Bimatoprost 0.03% has been shown to consistently reduce mean intraocular pressure (IOP) more than timolol 0.5% over 2 years. The implant has potential to improve adherence and reduce treatment burden in glaucoma.

ExcerptReferenceRelevance
"Bimatoprost has an IOP-lowering effect superior to that of latanoprost in glaucoma patients after switching from latanoprost. "( Switching efficacy on intraocular pressure from latanoprost to bimatoprost in eyes with open angle glaucoma: implication to the changes of central corneal thickness.
Sawada, A; Yamamoto, T, 2014
)
2.08
"The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma."( Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2).
Bacharach, J; Bejanian, M; Belalcázar, S; Chen, MY; Ferguson, G; Goodkin, ML; Guo, Q; Liu, J; Robinson, MR; Tatham, A; Thieme, H; Wirta, DL, 2021
)
1.34
"Bimatoprost has been reported to treat primary open-angle glaucoma (POAG) effectively. "( Efficacy of bimatoprost for the treatment of primary open-angle glaucoma: A protocol of systematic review and meta-analysis.
Liu, HW; Lu, YT; Meng, Y; Ren, YB, 2020
)
2.38
"The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma."( Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1).
Bejanian, M; Coote, M; Goodkin, ML; Guo, Q; Kolko, M; Medeiros, FA; Robinson, MR; Walters, TR; Weinreb, RN; Zhang, J, 2020
)
1.31
"Bimatoprost has known adnexal activity and was observed to increase nail growth at two clinical centers."( The effect of cutaneous prostaglandin application on nail growth, nail brittleness, and intraocular pressure.
Bueno, A; Palmer, DJ; Scheman, A; Tanna, AP, 2018
)
1.92
"Bimatoprost 0.03% has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects. "( Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies.
Arase, S; Daniels, S; Harii, K; Tsuboi, R; VanDenburgh, A; Weng, E, 2014
)
3.29
"Bimatoprost has an IOP-lowering effect superior to that of latanoprost in glaucoma patients after switching from latanoprost. "( Switching efficacy on intraocular pressure from latanoprost to bimatoprost in eyes with open angle glaucoma: implication to the changes of central corneal thickness.
Sawada, A; Yamamoto, T, 2014
)
2.08
"Bimatoprost 0.03% has been shown to consistently reduce mean intraocular pressure (IOP) more than timolol 0.5% over 2 years. "( Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4.
Batoosingh, AL; Cohen, JS; Gross, RL; Liu, CC; Safyan, E; Williams, RD, 2008
)
2.07
"Bimatoprost has also been suggested to lower intraocular pressure by behaving as a prodrug or, alternatively, by stimulating FP receptors directly."( Update on the mechanism of action of bimatoprost: a review and discussion of new evidence.
Krauss, AH; Woodward, DF, 2004
)
1.32
"Bimatoprost 0.03% q.d. has also been shown to provide significantly better diurnal IOP control than latanoprost 0.005% q.d., probably the most efficacious topical medication currently available."( Bimatoprost: a member of a new class of agents, the prostamides, for glaucoma management.
Cantor, LB, 2001
)
2.47
"Bimatoprost pharmacology has been extensively characterized by binding and functional studies at more than 100 drug targets, which comprise a diverse variety of receptors, ion channels, and transporters."( The pharmacology of bimatoprost (Lumigan).
Andrews, SW; Archeampong, A; Brar, B; Burk, RM; Chen, J; Chen, R; Garst, ME; Gil, DW; Kaplan, LJ; Kedzie, KM; Kharlamb, A; Krauss, AH; Lai, RK; Liang, Y; Ling, J; Madhu, C; Ni, J; Rix, P; Shi, L; Spada, CS; Tang-Liu, DD; Usansky, H; Usansky, J; Weber, A; Welty, D; Wheeler, LA; Woodward, DF; Yang, W, 2001
)
1.36
"Bimatoprost has been reported to cause changes in the pigmentation of the periorbital skin, eyelashes and iris, and increase eyelash growth."( Topical bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension.
Easthope, SE; Perry, CM, 2002
)
1.47

Actions

Bimatoprost shows lower ocular tolerability with higher incidence of side effects such as conjunctival hyperemia. It provided lower mean pressures than latanoprost at every time point throughout the study.

ExcerptReferenceRelevance
"Bimatoprost shows lower ocular tolerability with higher incidence of side effects such as conjunctival hyperemia."( Efficacy and safety of prostaglandin analogues in primary open-angle glaucoma or ocular hypertension patients: A meta-analysis.
Duan, X; Liu, K; Tang, W; Zhang, F, 2019
)
1.24
"Bimatoprost provided lower mean pressures than latanoprost at every time point throughout the study and was statistically superior in achieving low target pressures."( Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension.
Chen, K; Gandolfi, S; Simmons, ST; Sturm, R; VanDenburgh, AM,
)
1.15

Treatment

Bimatoprost treatment gave rise to a significantly lower mean IOP than timolol in all follow-up visits as from the first month (P<0.05) Eyes treated with Bim atoprost SR exhibited a transient increase in mean EVP that peaked at day 8, followed by a decrease to levels below baseline.

ExcerptReferenceRelevance
"4) Bimatoprost pretreatment did not attenuate PGF(2alpha)-induced Ca(2+) signals in Swiss 3T3 cells."( Pharmacological characterization of a novel antiglaucoma agent, Bimatoprost (AGN 192024).
Andrews, SW; Babusis, D; Bogardus, A; Burk, RM; Chen, J; Chen, R; Cherukury, M; Garst, ME; Gil, DW; Kedzie, KM; Kharlamb, A; Krauss, AH; Krauss, HA; Li, C; Liang, Y; Protzman, CE; Tang-Liu, DD; Welty, D; Wheeler, LA; Woodward, DF, 2003
)
1.07
"Bimatoprost SR-treated eyes exhibited a selective, sustained dilation of aqueous outflow vessels that was not observed in sham-treated eyes."( Bimatoprost sustained-release intracameral implant reduces episcleral venous pressure in dogs.
Almazan, A; Burke, J; Hughes, P; Lee, SS; Li, H; Miller, PE; Orilla, W; Robinson, MR; Shen, J; Struble, C; Zhang, J, 2018
)
2.64
"Bimatoprost-treated subjects had significantly greater increases in eyelash length, thickness, and darkness at the primary time point (month 4 in both studies; all P<0.001, study 1; P≤0.04, study 2)."( Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies.
Arase, S; Daniels, S; Harii, K; Tsuboi, R; VanDenburgh, A; Weng, E, 2014
)
2.57
"Bimatoprost-treated eyes demonstrated less long-term fluctuation in IOP compared with latanoprost-treated eyes in this six-month study. "( A comparison of long-term intraocular pressure fluctuation in patients treated with bimatoprost or latanoprost.
Bernstein, P; Hollander, DA; Simmons, ST, 2008
)
2.01
"Bimatoprost treatment was safe and well tolerated."( Efficacy and safety of switching from topical latanoprost to bimatoprost in patients with normal-tension glaucoma.
Baba, T; Fujimura, T; Hirooka, K; Mizote, M; Sato, S; Shiraga, F; Tenkumo, K; Ueda, H, 2011
)
1.33
"Bimatoprost treatment was associated with a higher incidence of trace-to-mild conjunctival hyperemia than latanoprost."( Effect of bimatoprost on patients with primary open-angle glaucoma or ocular hypertension who are nonresponders to latanoprost.
Cimino, L; Gandolfi, SA, 2003
)
1.44
"Bimatoprost treatment gave rise to a significantly lower mean IOP than timolol in all follow-up visits as from the first month (P<0.05). "( A 6-month assessment of bimatoprost 0.03% vs timolol maleate 0.5%: hypotensive efficacy, macular thickness and flare in ocular-hypertensive and glaucoma patients.
Garcia-Feijoo, J; Garcia-Sanchez, J; Larrosa, JM; Martin, E; Martinez-de-la-Casa, JM; Troyano, J, 2007
)
2.09
"A bimatoprost 0.03% qd treatment arm was used for validation of the study."( A double-masked, randomized, parallel comparison of a fixed combination of bimatoprost 0.03%/timolol 0.5% with non-fixed combination use in patients with glaucoma or ocular hypertension.
Hommer, A,
)
0.92
"Eyes treated with Bimatoprost SR exhibited a transient increase in mean EVP that peaked at day 8, followed by a decrease to levels below baseline."( Bimatoprost sustained-release intracameral implant reduces episcleral venous pressure in dogs.
Almazan, A; Burke, J; Hughes, P; Lee, SS; Li, H; Miller, PE; Orilla, W; Robinson, MR; Shen, J; Struble, C; Zhang, J, 2018
)
2.25
"Treatment with bimatoprost 0.03% for at least 12 months is safe, and long-term use is associated with a high degree of satisfaction."( A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis.
Campo, A; Caulkins, CA; Cox, SE; Davis, PG; Fagien, S; Gallagher, CJ; Yoelin, SG, 2014
)
0.99
"Treatment with bimatoprost was costlier than brimonidine with daily costs/eye Rs."( A pharmacoeconomic analysis to determine the relative cost-effectiveness of bimatoprost 0.03% eye drops and brimonidine 0.2% eye drops in patients of primary open-angle glaucoma/ocular hypertension.
Gupta, A; Natt, NK; Singh, G; Singh, T, 2014
)
0.97
"Treatment with bimatoprost produced a constant increase (1.85-8.83 μm) in CCT at all time-points of the study."( The effect of prostaglandin analogues on central corneal thickness of patients with chronic open-angle glaucoma: a 2-year study on 129 eyes.
Bafa, M; Georgopoulos, G; Mihas, C; Papaconstantinou, D; Stavrakas, P; Vergados, I, 2011
)
0.71
"Treatment with bimatoprost was generally well tolerated, with conjunctival hyperaemia (mostly mild), growth of eyelashes and ocular pruritus being commonly reported."( Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension.
Curran, MP, 2009
)
2.14
"Treatment with bimatoprost increases the percentage of eyelash follicles in anagen at any one time. "( Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth.
Cohen, JL, 2010
)
0.96

Toxicity

TNFalpha induced or stimulated expression of the three inflammatory markers, whereas the PGF2alpha, latanoprost, travoprost and bimatoprost solutions did not. The most commonly reported adverse event was conjunctival hyperaemia.

ExcerptReferenceRelevance
" Both treatment regimens were safe and well tolerated, with no significant between-group differences in reports of specific adverse events."( Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost.
Cooke, D; Dirks, M; DuBiner, H; Felix, C; Stewart, WC; VanDenburgh, AM, 2001
)
0.62
"03% provided better diurnal IOP control than latanoprost and was safe and well tolerated in patients with ocular hypertension and glaucoma."( Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost.
Cooke, D; Dirks, M; DuBiner, H; Felix, C; Stewart, WC; VanDenburgh, AM, 2001
)
0.62
" Safety parameters included adverse events, hyperemia grading, laser flare meter analysis, heart rate, and blood pressure."( Comparison of the ocular hypotensive lipid AGN 192024 with timolol: dosing, efficacy, and safety evaluation of a novel compound for glaucoma management.
Batoosingh, A; Cheetham, J; David, R; Felix, C; Laibovitz, RA; Rosenthal, A; VanDenburgh, AM, 2001
)
0.31
" All treatment regimens were safe and well tolerated, with no clinically significant effects on heart rate or blood pressure and no between-group differences in the incidence of adverse events."( Comparison of the ocular hypotensive lipid AGN 192024 with timolol: dosing, efficacy, and safety evaluation of a novel compound for glaucoma management.
Batoosingh, A; Cheetham, J; David, R; Felix, C; Laibovitz, RA; Rosenthal, A; VanDenburgh, AM, 2001
)
0.31
" AGN 192024 was safe and well tolerated, and it provided superior ocular hypotensive efficacy and diurnal IOP control compared with timolol in patients with ocular hypertension and glaucoma."( Comparison of the ocular hypotensive lipid AGN 192024 with timolol: dosing, efficacy, and safety evaluation of a novel compound for glaucoma management.
Batoosingh, A; Cheetham, J; David, R; Felix, C; Laibovitz, RA; Rosenthal, A; VanDenburgh, AM, 2001
)
0.31
" The impact on cellular viability and apoptosis in the same cell line was evaluated, to address the possible proinflammatory and/or toxic origin of the most frequent clinical impairments induced by prostanoids (i."( In vitro study of inflammatory potential and toxicity profile of latanoprost, travoprost, and bimatoprost in conjunctiva-derived epithelial cells.
Baudouin, C; Brignole-Baudouin, F; Guenoun, JM; Pauly, A; Rat, P; Warnet, JM, 2005
)
0.55
"TNFalpha induced or stimulated expression of the three inflammatory markers, whereas the PGF2alpha, latanoprost, travoprost, and bimatoprost solutions did not induce an increase in these markers and even produced a marked reduction of ICAM-1 and PECAM-1 expression in those solutions most concentrated in BAC, thus suggesting a toxic phenomenon in cellular membranes induced by the preservative rather than the medication itself."( In vitro study of inflammatory potential and toxicity profile of latanoprost, travoprost, and bimatoprost in conjunctiva-derived epithelial cells.
Baudouin, C; Brignole-Baudouin, F; Guenoun, JM; Pauly, A; Rat, P; Warnet, JM, 2005
)
0.75
" Bimatoprost was well-tolerated; the most commonly reported adverse event was conjunctival hyperaemia (19."( Efficacy and safety of bimatoprost for the treatment of open-angle glaucoma and ocular hypertension: a three-month, open-label study in community-based practices in Thailand.
Iemsomboon, W; Wanichwecha-Rungruang, B, 2005
)
1.55
"We observed conjunctival hyperemia as the most common side effect of bimatoprost and travoprost."( Comparison of ocular surface side effects of topical travoprost and bimatoprost.
Alagöz, G; Bayer, A; Boran, C; Elçioğlu, M; Kükner, A; Serin, D, 2008
)
0.82
" Safety measures included adverse events, biomicroscopy, ophthalmoscopy, visual acuity and visual field."( Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4.
Batoosingh, AL; Cohen, JS; Gross, RL; Liu, CC; Safyan, E; Williams, RD, 2008
)
0.63
" No safety concerns developed during long-term bimatoprost treatment; two patients in the timolol treatment group discontinued after month 36 because of adverse events."( Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4.
Batoosingh, AL; Cohen, JS; Gross, RL; Liu, CC; Safyan, E; Williams, RD, 2008
)
0.88
"To document patient/physician perceptions of adverse effects and their relationship to medication changes among patients prescribed prostaglandin analogs."( The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence.
Gelb, L; Hahn, SR; Kim, EE; Tan, H; Zimmerman, TJ, 2009
)
0.35
" Frequency of adverse effects noted by physicians and associations with medication change decisions were examined in charted data."( The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence.
Gelb, L; Hahn, SR; Kim, EE; Tan, H; Zimmerman, TJ, 2009
)
0.35
" Adverse effects were the second most common reasons noted by physicians for switching medications after lack of efficacy (19% vs."( The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence.
Gelb, L; Hahn, SR; Kim, EE; Tan, H; Zimmerman, TJ, 2009
)
0.35
"Ocular adverse effects, particularly hyperemia, negatively affect patient continuation with therapy and switching."( The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence.
Gelb, L; Hahn, SR; Kim, EE; Tan, H; Zimmerman, TJ, 2009
)
0.35
" Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded."( Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study.
Buchholz, P; Feuerhake, C; Kimmich, F, 2009
)
0.59
" Few adverse events occurred during the treatment period."( Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study.
Buchholz, P; Feuerhake, C; Kimmich, F, 2009
)
0.59
"5% was effective, well tolerated, and safe in a broad patient population."( Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study.
Buchholz, P; Feuerhake, C; Kimmich, F, 2009
)
0.59
"Latanoprost, travoprost, and bimatoprost are prostaglandin or prostamide-type ocular hypotensive medications, all of which are effective and safe for lowering intraocular pressure (IOP)."( Prostaglandin efficacy and safety study undertaken by race (the PRESSURE study).
Ahmed, II; Birt, CM; Buys, YM; Trope, GE, 2010
)
0.65
" Adverse events and intraocular pressure were assessed, and subjects completed health outcomes questionnaires."( Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth.
Earl, M; Walt, JG; Yoelin, S, 2010
)
0.6
" No serious or unexpected adverse events were reported."( Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth.
Earl, M; Walt, JG; Yoelin, S, 2010
)
0.6
"Bimatoprost was found safe for eyelid application and was associated with enhanced eyelash growth."( Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth.
Earl, M; Walt, JG; Yoelin, S, 2010
)
2.04
" We present 2 cases of a newly described side effect of both these topical agents in terms of periorbital fat atrophy."( Periorbital fat atrophy - an unfamiliar side effect of prostaglandin analogues.
Ghazi-Nouri, S; Jayaprakasam, A, 2010
)
0.36
" Bimatoprost treatment was safe and well tolerated."( Efficacy and safety of switching from topical latanoprost to bimatoprost in patients with normal-tension glaucoma.
Baba, T; Fujimura, T; Hirooka, K; Mizote, M; Sato, S; Shiraga, F; Tenkumo, K; Ueda, H, 2011
)
1.52
" The gastro-intestinal effects are among the most reported adverse effects upon topical application of PGAs."( Possible mechanism for the gastro-intestinal adverse effects upon topical application of Prostaglandin F₂α analogs.
Cai, S; Li, X; Liu, X; Yan, N; Zhou, X, 2013
)
0.39
" Mild ocular redness was the commonest side effect in both the groups but was not significant in either group."( Comparison of the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma.
Chander, A; Kapoor, H; Thomas, S,
)
0.4
"Both drugs lowered IOP effectively but bimatoprost showed a greater reduction in the mean IOP than did travoprost at 12 weeks and both are safe for ocular use."( Comparison of the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma.
Chander, A; Kapoor, H; Thomas, S,
)
0.67
" The safety outcome measures included the rate of medication-related symptoms, physical signs, reported adverse events, and the level of conjunctival hyperemia."( Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China.
Fang, A; Hou, J; Ji, J; Liu, Q; Sun, X; Wang, K; Wu, L; Xu, L; Yao, K; Yuan, Z; Zhang, M; Zhao, J, 2014
)
0.65
" The most common adverse event was conjunctival hyperemia, mainly of trace and mild intensity."( Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China.
Fang, A; Hou, J; Ji, J; Liu, Q; Sun, X; Wang, K; Wu, L; Xu, L; Yao, K; Yuan, Z; Zhang, M; Zhao, J, 2014
)
0.65
" Adverse events were collected and slit-lamp examinations were performed to assess safety."( Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension.
Chen, X; Dong, Y; Fang, A; Hu, Y; Ling, Z; Liu, D; Sun, W; Sun, X; Wang, Y; Xing, Y; Ye, J; Yin, Z; Zhang, M, 2014
)
0.71
" Adverse events occurred in 26."( Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension.
Chen, X; Dong, Y; Fang, A; Hu, Y; Ling, Z; Liu, D; Sun, W; Sun, X; Wang, Y; Xing, Y; Ye, J; Yin, Z; Zhang, M, 2014
)
0.71
" Charts were reviewed for medication usage characteristics and adverse events (AEs)."( A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis.
Campo, A; Caulkins, CA; Cox, SE; Davis, PG; Fagien, S; Gallagher, CJ; Yoelin, SG, 2014
)
0.63
" No drug-related serious adverse events were reported."( Long-term safety and efficacy of bimatoprost solution 0·03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomized controlled trial.
Ahluwalia, G; Beddingfield, FC; Glaser, DA; Griffiths, T; Hossain, P; Perkins, W; Weng, E, 2015
)
0.7
" Adverse effects of the treatment were minimal and similar between the 2 groups."( Efficacy and Safety of Bimatoprost 0.01% for the Treatment of Eyebrow Hypotrichosis: A Randomized, Double-Blind, Vehicle-Controlled Study.
Chanasumon, N; Sriphojanart, T; Suchonwanit, P, 2019
)
0.82
"03% bimatoprost are effective and safe for the treatment of eyebrow hypotrichosis."( Comparison of the efficacy and safety of using 0.01% versus 0.03% bimatoprost for the treatment of eyebrow hypotrichosis: A randomized, double-blind, split-face, comparative study.
Chanasumon, N; Harnchoowong, S; Sriphojanart, T; Suchonwanit, P, 2020
)
1.35
" Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD)."( Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2).
Bacharach, J; Bejanian, M; Belalcázar, S; Chen, MY; Ferguson, G; Goodkin, ML; Guo, Q; Liu, J; Robinson, MR; Tatham, A; Thieme, H; Wirta, DL, 2021
)
0.86

Pharmacokinetics

ExcerptReferenceRelevance
"To assess the pharmacokinetic (PK)/pharmacodynamic (PD) relationship following intracameral Bimatoprost sustained-release (SR) implants (8, 15, 30, and 60 µg) in dogs to determine the optimal investigative dose in humans."( Nonclinical Pharmacokinetic and Pharmacodynamic Assessment of Bimatoprost Following a Single Intracameral Injection of Sustained-Release Implants.
Attar, M; Robinson, MR; Shen, J; Struble, C, 2020
)
1.02

Compound-Compound Interactions

ExcerptReferenceRelevance
"03% (PGF2α analogues) combined with narrowband ultraviolet B (NB-UVB) was reported to be an effective treatment for vitiligo."( The efficacy of bimatoprost ophthalmic solution combined with NB-UVB phototherapy in non-segmental and segmental vitiligo: a single-blind randomized controlled study.
Apinuntham, C; Chaiyabutr, C; Charoenpipatsin, N; Likittanasombat, S; Pruksaeakanan, C; Silpa-Archa, N; Wongpraparut, C, 2023
)
1.26

Bioavailability

ExcerptReferenceRelevance
" These findings may be valuable in developing formulation strategies to optimize ocular bioavailability of topically administered ocular agents."( Expression of multidrug resistance associated protein 5 (MRP5) on cornea and its role in drug efflux.
Herndon, BL; Karla, PK; Mitra, A; Pal, D; Quinn, TL; Thomas, P, 2009
)
0.35

Dosage Studied

Both BTFC dosing regimens significantly reduce 24 h IOP in XFG compared with bimatoprost monotherapy. After a 1 week run-in period wit after a single dosage of bim atoprost, cyclodialysis was revealed in the patient's affected eye.

ExcerptRelevanceReference
" Twice-daily dosing of bimatoprost also provided significantly greater mean reductions in IOP than timolol at most time points but was not as effective as once-daily dosing."( Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial.
Brandt, JD; Chen, K; VanDenburgh, AM; Whitcup, SM, 2001
)
0.9
" BID dosing of bimatoprost also provided significantly greater mean IOP reductions than timolol at most timepoints, but was not as effective as QD dosing."( Six-month comparison of bimatoprost once-daily and twice-daily with timolol twice-daily in patients with elevated intraocular pressure.
Brandt, J; Sherwood, M, 2001
)
0.97
" The reduction in IOP was maintained throughout the 24-hour dosage interval."( Topical bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension.
Easthope, SE; Perry, CM, 2002
)
0.75
"We evaluated conjunctival hyperemia by a standard photographic measure at the slit lamp and by anterior segment photographs in healthy subjects after dosing for 5 days with latanoprost, bimatoprost, or travoprost."( Conjunctival hyperemia in healthy subjects after short-term dosing with latanoprost, bimatoprost, and travoprost.
Jackson, AL; Kolker, AE; Leech, J; Stewart, JA; Stewart, WC, 2003
)
0.73
"A single centered, active-controlled, three-period crossover comparison that evaluated conjunctival and corneal punctate staining, by grade and individual stains, in healthy subjects after dosing for five days in one eye with latanoprost, bimatoprost, or travoprost."( Corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy subjects.
Jackson, AL; Jenkins, JN; Stewart, JA; Stewart, WC, 2003
)
0.76
"33) or at 1 hour after dosing (latanoprost 23."( Corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy subjects.
Jackson, AL; Jenkins, JN; Stewart, JA; Stewart, WC, 2003
)
0.58
" The following 5 different dosing protocols were studied: latanoprost with bimatoprost added, bimatoprost with latanoprost added, latanoprost with travoprost added, travoprost with latanoprost added, and latanoprost with a second dose of latanoprost added."( Additivity of bimatoprost or travoprost to latanoprost in glaucomatous monkey eyes.
Gagliuso, DJ; Mittag, TW; Podos, SM; Wang, RF, 2004
)
0.91
"15% unoprostone isopropyl solution induced no significant ocular side effects in normal cats when dosed over a 10-day treatment period."( The effects of bimatoprost and unoprostone isopropyl on the intraocular pressure of normal cats.
Bartoe, JT; Brightman, AH; Davidson, HJ; Horton, MT; Jung, Y,
)
0.48
" Acid metabolites were below the limit of quantitation in all samples taken 12 h after dosing and in all samples from placebo-treated patients."( Levels of bimatoprost acid in the aqueous humour after bimatoprost treatment of patients with cataract.
Acheampong, A; Cantor, LB; Catoira, Y; Cortes, A; Hoop, J; Valluri, S; Wheeler, LA; Woodward, DF; Wudunn, D; Yung, CW, 2007
)
0.74
" Treatment with a fixed combination may, therefore, increase compliance as a result of simplifying the dosage regimen."( Efficacy and safety of bimatoprost/timolol fixed combination in the treatment of glaucoma or ocular hypertension.
Martinez, A; Sanchez, M, 2008
)
0.66
" Patients randomised to bimatoprost twice daily had been switched to bimatoprost once daily dosing at month 24 (bimatoprost twice daily/once daily treatment group), and continued with once daily dosing through month 48 (n = 39)."( Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4.
Batoosingh, AL; Cohen, JS; Gross, RL; Liu, CC; Safyan, E; Williams, RD, 2008
)
0.93
" Patients with an IOP of 22-29 mmHg inclusive at 8 AMwere randomized to either bimatoprost dosed each evening or DTFC twice-daily."( A comparison of dorzolamide/timolol-fixed combination versus bimatoprost in patients with open-angle glaucoma who are poorly controlled on latanoprost.
Nelson, LA; Sharpe, ED; Stewart, JA; Stewart, WC; Williams, RD, 2008
)
0.81
"Both BTFC dosing regimens significantly reduce 24 h IOP in XFG compared with bimatoprost monotherapy."( Twenty-four-hour intraocular pressure control with bimatoprost and the bimatoprost/timolol fixed combination administered in the morning, or evening in exfoliative glaucoma.
Embeslidis, T; Georgiadou, I; Haidich, AB; Holló, G; Irkec, M; Konstas, AG; Melamed, S; Mikropoulos, D; Tsironi, S, 2010
)
0.84
" After a 1 week run-in period with bimatoprost all patients were treated with bimatoprost dosed once in the morning for 1 month, after which dorzolamide was added twice daily for 2 months."( The additive effect of dorzolamide hydrochloride (Trusopt) and a morning dose of bimatoprost (Lumigan) on intraocular pressure and retrobulbar blood flow in patients with primary open-angle glaucoma.
Ehrlich, R; Fuksinska, B; Harris, A; Robaszkiewicz, J; Siemiatkowska, A; Siesky, B; Stankiewicz, A; Wierzbowska, J; Zegadlo, A, 2010
)
0.86
"8 years, range 33-80; 68 women) with POAG received bimatoprost dosed once in the morning for 1 month, after which dorzolamide was added twice daily for 2 months."( Intraocular pressure and ocular hemodynamics in patients with primary open-angle glaucoma treated with the combination of morning dosing of bimatoprost and dorzolamide hydrochloride.
Ehrlich, R; Grabska-Liberek, I; Harris, A; Misiuk-Hojło, M; Mulak, M; Romanowska-Dixon, B; Sierdziński, J; Siesky, B; Stankiewicz, A; Szuścik, I; Wasyluk, J; Wierzbowska, J, 2011
)
0.82
"UBM revealed cyclodialysis in the patient's affected eye after a single dosage of bimatoprost."( A case hypersensitive to bimatoprost and dexamethasone.
Li, X; Liu, G; Liu, X; Wang, Y; Xiang, H; Yu, W, 2011
)
0.9
"Bimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components."( Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension.
Chen, X; Dong, Y; Fang, A; Hu, Y; Ling, Z; Liu, D; Sun, W; Sun, X; Wang, Y; Xing, Y; Ye, J; Yin, Z; Zhang, M, 2014
)
2.16
"To compare the dose-response profiles of bimatoprost sustained-release implant (Bimatoprost SR) and topical bimatoprost in lowering intraocular pressure (IOP) in normotensive beagle dogs."( Dose-Response of Intracameral Bimatoprost Sustained-Release Implant and Topical Bimatoprost in Lowering Intraocular Pressure.
Almazan, A; Dibas, M; Lee, SS; Robinson, MR, 2019
)
1.07
"There is a limit beyond which increasing either the concentration of a prostaglandin analog (PGA) or its dosing frequency fails to produce increases in ocular hypotensive efficacy with topical dosing."( Episcleral Venous Pressure and the Ocular Hypotensive Effects of Topical and Intracameral Prostaglandin Analogs.
Lee, SS; Robinson, MR; Weinreb, RN, 2019
)
0.51
" Several studies are underway to investigate mechanisms of action and to better understand safe and effective dosing of medications in this class."( Intracameral sustained release bimatoprost implants (Durysta).
Lin, MM; Sirinek, PE, 2022
)
1.01
" Intraocular pressure (IOP), ophthalmic artery resistive index (OA-RI), and electroretinogram (ERG) data were collected prior to dosing and at different time points postdosing."( NCX 470 Exerts Retinal Cell Protection and Enhances Ophthalmic Artery Blood Flow After Ischemia/Reperfusion Injury of Optic Nerve Head and Retina.
Bastia, E; Brambilla, S; Galli, C; Impagnatiello, F; Lucarini, L; Marri, S; Masini, E; Provensi, G; Sgambellone, S; Villano, S, 2023
)
0.91
"NCX 470 repeated ocular dosing ameliorates ocular hemodynamics and retinal cell dysfunction caused by ischemia/reperfusion via nitric oxide- and bimatoprost-mediated mechanisms."( NCX 470 Exerts Retinal Cell Protection and Enhances Ophthalmic Artery Blood Flow After Ischemia/Reperfusion Injury of Optic Nerve Head and Retina.
Bastia, E; Brambilla, S; Galli, C; Impagnatiello, F; Lucarini, L; Marri, S; Masini, E; Provensi, G; Sgambellone, S; Villano, S, 2023
)
1.11
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antiglaucoma drugAny drug which can be used to prevent or alleviate glaucoma, a disease in which the optic nerve is damaged, resulting in progressive, irreversible loss of vision. It is often, though not always, associated with increased pressure of the fluid in the eye.
antihypertensive agentAny drug used in the treatment of acute or chronic vascular hypertension regardless of pharmacological mechanism.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (4)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)40.40000.11007.190310.0000AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (41)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (24)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (17)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (23)

Assay IDTitleYearJournalArticle
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473737AUC in human administered intraocularly as 1 drop QD of 0.03% solution after 24 hrs2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473742Drug concentration at steady state in human administered intraocularly as 1 drop QD of 0.03% solution after 24 hrs2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473743Ratio of drug concentration at steady state in human administered intraocularly as 1 drop QD of 0.03% solution after 24 hrs to IC50 for human BSEP overexpressed in Sf9 insect cells2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1674156Drug release in pH 7.2 simulated tear fluid measured at 240 hrs by HPLC method2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
Ocular Disease Therapeutics: Design and Delivery of Drugs for Diseases of the Eye.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1346394Human FP receptor (Prostanoid receptors)2003The Journal of pharmacology and experimental therapeutics, May, Volume: 305, Issue:2
Pharmacological characterization of a novel antiglaucoma agent, Bimatoprost (AGN 192024).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (543)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's241 (44.38)29.6817
2010's226 (41.62)24.3611
2020's76 (14.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 59.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index59.04 (24.57)
Research Supply Index6.66 (2.92)
Research Growth Index4.54 (4.65)
Search Engine Demand Index160.03 (26.88)
Search Engine Supply Index3.15 (0.95)

This Compound (59.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials184 (30.98%)5.53%
Reviews79 (13.30%)6.00%
Case Studies67 (11.28%)4.05%
Observational11 (1.85%)0.25%
Other253 (42.59%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (149)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension [NCT02507687]Phase 3240 participants (Actual)Interventional2015-08-27Completed
Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma [NCT01361841]141 participants (Anticipated)Interventional2009-01-31Recruiting
Topical Bimatoprost for Chemical Blepharoplasty [NCT02830776]Early Phase 115 participants (Actual)Interventional2016-11-30Completed
Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma [NCT03966560]Phase 496 participants (Actual)Interventional2014-01-31Completed
[NCT02505776]1,699 participants (Actual)Observational2014-12-08Completed
Effect of Bimatoprost (Lumigan) in Gel Suspension Applied to the Eyelashes on Eyelash Growth [NCT00773136]21 participants (Actual)Interventional2008-02-29Completed
A Randomised Control Study to Investigate if the Continuation of Prostaglandin Analogue Treatments in the Post-operative Phase of Glaucoma Patients Undergoing Cataract Surgery Increases the Incidence of Cystoid Macular Oedema. [NCT03292796]Phase 256 participants (Actual)Interventional2016-12-07Completed
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension [NCT03891446]Phase 3600 participants (Anticipated)Interventional2019-03-27Enrolling by invitation
A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine [NCT03419715]Phase 270 participants (Actual)Interventional2018-01-05Active, not recruiting
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients. [NCT04898387]Phase 3554 participants (Actual)Interventional2021-03-26Completed
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients [NCT03825380]Phase 3485 participants (Actual)Interventional2018-11-23Completed
Stop Retinal Ganglion Cell Dysfunction Study [NCT02390284]Phase 3500 participants (Anticipated)Interventional2015-09-30Active, not recruiting
Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo [NCT03487042]Phase 440 participants (Anticipated)Interventional2018-05-31Not yet recruiting
The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety [NCT01200251]Phase 320 participants (Actual)Interventional2007-02-28Completed
Efficacy and Safety of Topical Bimatoprost Solution 0.03% in Stable Vitiligo:A Preliminary Study [NCT01202513]Phase 420 participants (Actual)Interventional2010-08-31Withdrawn(stopped due to regulatory reasons)
A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension [NCT01298700]Phase 4806 participants (Actual)Interventional2011-05-31Completed
Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy [NCT01263444]Phase 447 participants (Actual)Interventional2011-03-31Completed
A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG) [NCT02863705]Phase 4118 participants (Actual)Interventional2016-07-05Completed
The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation [NCT00705757]Phase 489 participants (Actual)Interventional2008-03-31Completed
A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) [NCT05335122]Phase 2105 participants (Anticipated)Interventional2022-03-16Active, not recruiting
Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues. [NCT02155049]Phase 310 participants (Actual)Interventional2014-11-30Completed
A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-an [NCT02742649]Phase 1/Phase 255 participants (Actual)Interventional2016-04-30Completed
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5% [NCT06120842]Phase 1/Phase 2140 participants (Anticipated)Interventional2023-10-13Recruiting
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers [NCT05729594]Phase 140 participants (Actual)Interventional2023-02-27Completed
Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma [NCT04981886]Phase 4115 participants (Anticipated)Interventional2021-08-31Not yet recruiting
Prostaglandin F2-alpha Eye Drops (Bimatoprost) in Thyroid Eye Disease: a Randomised Controlled Double Blind Crossover Trial [NCT02059655]Phase 431 participants (Actual)Interventional2014-11-30Completed
Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures [NCT02154217]Phase 3200 participants (Actual)InterventionalCompleted
[NCT01594970]Phase 4800 participants (Actual)Interventional2012-03-31Completed
Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler) [NCT05938699]Phase 2/Phase 320 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension. [NCT00941096]Phase 430 participants (Anticipated)Interventional2009-07-31Completed
The Role of Bimatoprost in Graves' Periorbitopathy [NCT03708627]Early Phase 13 participants (Anticipated)Interventional2017-11-01Recruiting
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension [NCT01157364]Phase 1/Phase 2109 participants (Actual)Interventional2010-09-23Completed
[NCT00440011]Phase 4266 participants (Actual)Interventional2006-08-31Completed
[NCT01217606]Phase 3185 participants (Actual)Interventional2011-01-31Completed
[NCT00651859]Phase 2111 participants (Actual)Interventional2002-11-30Completed
Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia [NCT02848300]Phase 111 participants (Actual)Interventional2016-07-31Completed
Expanded Access to Bimatoprost [NCT05338606]0 participants Expanded AccessAvailable
[NCT00693420]Phase 3278 participants (Actual)Interventional2007-04-30Completed
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension [NCT02636946]Phase 3144 participants (Actual)Interventional2016-02-24Completed
Primary Glaucoma Treatment Trial in Kenya and South Africa - SLT vs. Medication [NCT02774811]15 participants (Actual)Interventional2014-02-28Terminated(stopped due to Unable to maintain a functional laser in the environment)
Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients [NCT00999557]0 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to Study was never opened)
Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Eyebrow Hypotrichosis: A Phase 4 Investigator Initiated Study [NCT01891487]Phase 433 participants (Actual)Interventional2013-05-31Completed
Intraocular Pressure and Tolerability Study of Preservative Free Bimatoprost 0.03% Unit Dose (BUDPF) or Preservative Free Latanoprost 0.005% Unit Dose (LUDPF) (Monoprost®) in Patients With Ocular Hypertension or Glaucoma: A Randomized, Single Masked, 3 Mo [NCT01975714]Phase 467 participants (Actual)Interventional2013-10-31Completed
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With Primary Open Angle Glaucoma [NCT01978015]Phase 469 participants (Actual)Interventional2011-10-31Completed
Comparison of Bimatoprost and Lataprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study [NCT00567788]60 participants (Anticipated)Interventional2006-07-31Active, not recruiting
[NCT01325337]Phase 2307 participants (Actual)Interventional2011-06-30Completed
Evaluation of the Safety of GANFORT® (Bimatoprost 0.03% Plus Timolol 0.5%) Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension [NCT02571712]Phase 4750 participants (Actual)Interventional2015-11-10Completed
[NCT00652496]Phase 2249 participants (Actual)Interventional2005-01-31Completed
Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men [NCT02676310]Phase 153 participants (Actual)Interventional2016-03-31Terminated
Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo [NCT01387906]Phase 420 participants (Actual)Interventional2011-03-31Completed
[NCT00332072]Phase 3541 participants (Actual)Interventional2001-08-31Completed
[NCT00332540]Phase 3520 participants (Actual)Interventional2001-08-31Completed
A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan). [NCT00847483]Phase 4375 participants (Actual)Interventional2002-01-31Completed
Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata [NCT00187577]14 participants (Actual)Interventional2005-06-30Completed
The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish [NCT01507584]23 participants (Actual)Interventional2011-08-31Completed
[NCT01833741]Phase 41,137 participants (Actual)Interventional2009-12-31Completed
Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension [NCT00348023]Phase 40 participants InterventionalCompleted
A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension [NCT00348062]Phase 40 participants InterventionalCompleted
[NCT01325350]Phase 2306 participants (Actual)Interventional2011-06-30Completed
A 3-month, 4-centre, Crossover, Double-masked Study Investigating the 24-hour Intraocular Pressure Control With the Bimatoprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Exfoliative Glaucoma [NCT00486486]Phase 460 participants (Actual)Interventional2007-03-31Completed
[NCT01241240]Phase 3192 participants (Actual)Interventional2011-03-31Completed
[NCT00958035]Phase 489 participants (Actual)Interventional2009-11-30Completed
[NCT01016691]Phase 247 participants (Actual)Interventional2009-10-31Completed
Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous. [NCT00355446]Phase 448 participants Interventional2001-07-31Completed
[NCT01853085]1,830 participants (Actual)Observational2013-04-01Completed
An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures [NCT00329095]Phase 460 participants Interventional2005-12-31Completed
[NCT00332059]Phase 3445 participants (Actual)Interventional2003-05-31Completed
[NCT00539526]Phase 4106 participants (Actual)Interventional2007-09-30Completed
[NCT00541242]Phase 4586 participants (Actual)Interventional2007-12-31Completed
[NCT00716742]1,099 participants (Actual)Observational2004-09-30Completed
[NCT01177098]Phase 3561 participants (Actual)Interventional2010-10-31Completed
A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects [NCT01391286]Phase 336 participants (Actual)Interventional2011-07-01Completed
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension [NCT04499248]Phase 1/Phase 296 participants (Anticipated)Interventional2020-11-16Recruiting
Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study [NCT01542710]80 participants (Actual)Interventional2011-01-31Completed
[NCT01589510]419 participants (Actual)Observational2012-04-30Completed
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles [NCT02170662]Phase 233 participants (Actual)Interventional2009-11-30Completed
[NCT00273455]Phase 434 participants Interventional2006-01-31Completed
[NCT00300443]Phase 2/Phase 3561 participants (Actual)Interventional2005-12-31Completed
Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004% [NCT00347802]Phase 40 participants InterventionalCompleted
Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost [NCT00347841]Phase 40 participants InterventionalCompleted
[NCT01064882]Phase 2104 participants (Actual)Interventional2010-03-31Completed
The 24 Control of IOP in Ocular Hypertension: a Cross-over Study on Inflow Versus Outflow Drugs. [NCT01655758]Phase 461 participants (Actual)Interventional2002-01-31Completed
A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyelash Prominence in Japanese Subjects With Hypotrichosis o [NCT01391273]Phase 3173 participants (Actual)Interventional2011-07-01Completed
[NCT01698554]Phase 3464 participants (Actual)Interventional2012-11-30Completed
A Randomized ( 1:1), Double-Masked, Multi-Center, Two-Treatment, Single-Period, Parallel Design, Mutiple Dose Bioequivalence Study With Clinical End-Point of Bimatoprost Ophthalmic Solution 0.01% of Mankind Pharma Limited With LUMIGAN (Bimatoprost Ophthal [NCT04890106]Phase 3310 participants (Actual)Interventional2021-10-02Completed
[NCT01170884]Phase 4121 participants (Actual)Interventional2009-12-31Completed
[NCT01489670]387 participants (Actual)Observational2011-09-30Completed
[NCT01628588]854 participants (Actual)Observational2010-03-31Completed
[NCT01904721]Phase 2244 participants (Actual)Interventional2013-08-31Completed
[NCT02061683]Phase 4263 participants (Actual)Interventional2010-04-19Completed
[NCT01765764]Phase 3357 participants (Actual)Interventional2013-03-13Completed
[NCT01830140]Phase 3466 participants (Actual)Interventional2013-07-31Completed
[NCT01547598]Phase 4135 participants (Actual)Interventional2011-12-31Completed
Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata [NCT05600673]Phase 1/Phase 230 participants (Actual)Interventional2019-01-01Completed
[NCT00809848]Phase 1/Phase 2172 participants (Actual)Interventional2009-02-28Completed
24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma [NCT01448837]Phase 437 participants (Actual)Interventional2010-04-30Completed
[NCT01110499]Phase 2163 participants (Actual)Interventional2010-06-30Completed
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients. [NCT01927406]Phase 40 participants (Actual)Interventional2014-06-30Withdrawn(stopped due to Funding source unavailable)
[NCT01189279]Phase 142 participants (Actual)Interventional2010-10-31Completed
[NCT01243567]Phase 481 participants (Actual)Interventional2010-06-01Completed
[NCT01001195]Phase 2165 participants (Actual)Interventional2009-11-30Completed
[NCT01525173]Phase 4137 participants (Actual)Interventional2012-01-31Completed
[NCT01628601]392 participants (Actual)Observational2010-05-31Completed
[NCT01632423]10,337 participants (Actual)Observational2010-02-28Completed
[NCT01646151]2,580 participants (Actual)Observational2012-05-31Completed
Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle [NCT01664039]Phase 4104 participants (Actual)Interventional2012-09-30Completed
[NCT01023841]Phase 471 participants (Actual)Interventional2010-06-01Completed
[NCT01099774]Phase 3597 participants (Actual)Interventional2010-05-01Completed
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension [NCT03850782]Phase 3515 participants (Actual)Interventional2019-02-28Active, not recruiting
[NCT01253902]Phase 4164 participants (Actual)Interventional2010-12-31Completed
24-hour IOP-lowering Effect of 0.01% Bimatoprost [NCT01271686]Phase 416 participants (Actual)Interventional2011-01-31Completed
A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects [NCT05401357]Phase 3168 participants (Anticipated)Interventional2022-06-29Recruiting
A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocul [NCT02358369]Phase 2156 participants (Actual)Interventional2015-01-19Completed
Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting [NCT04828057]50 participants (Actual)Observational2021-09-01Completed
An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004 [NCT02537015]Phase 281 participants (Actual)Interventional2015-08-10Completed
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension [NCT02250651]Phase 3528 participants (Actual)Interventional2014-12-15Completed
A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo [NCT04738149]Early Phase 14 participants (Actual)Interventional2021-11-02Completed
[NCT02020512]Phase 487 participants (Actual)Interventional2011-07-31Completed
[NCT01291108]Phase 2125 participants (Actual)Interventional2011-04-30Completed
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients [NCT05397600]Phase 3684 participants (Actual)Interventional2022-06-22Active, not recruiting
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance [NCT02017327]Phase 4379 participants (Actual)Interventional2013-12-31Completed
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension [NCT02247804]Phase 3594 participants (Actual)Interventional2014-12-15Completed
[NCT02176356]Phase 4116 participants (Actual)Interventional2014-06-30Completed
IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy [NCT02471105]Phase 467 participants (Anticipated)Interventional2015-09-30Recruiting
Evaluation of Laser-assisted Drug Delivery of Bimatoprost for the Treatment of Hypertrophic Scar Hypopigmentation: A Within Patient-Controlled Trial in Skin of Color [NCT06122090]Phase 225 participants (Anticipated)Interventional2023-07-18Recruiting
A PK Study to Assess the Relative Systemic Exposure to Bimatoprost and Bimatoprost Acid After Administration of a Single 13 mg Bimatoprost Ocular Insert for 1 Week in Medically Stable Adult Subjects With or Without Open-Angle Glaucoma or Ocular Hypertensi [NCT02444767]Phase 111 participants (Actual)Interventional2015-03-31Completed
A Multi-Center, Evaluator -Masked, Randomized, Parallel Group, Active Controlled, Comparative Study of SPARC's SDP-133 Once Daily Compared With Lumigan ® 0.01% (Bimatoprost Ophthalmic Solution) in Subjects With Open Angle Glaucoma or Ocular Hypertension [NCT03927443]Phase 30 participants (Actual)Interventional2019-06-10Withdrawn(stopped due to [Sponsors decision])
[NCT01229423]Phase 462 participants (Actual)Interventional2009-11-30Completed
[NCT01448525]Phase 488 participants (Actual)Interventional2011-10-31Completed
[NCT01623479]585 participants (Actual)Observational2010-11-19Completed
Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue [NCT02419508]Phase 4290 participants (Actual)Interventional2015-08-07Completed
[NCT01426113]Phase 36 participants (Actual)Interventional2011-09-30Terminated(stopped due to Study terminated due to corporate decision.)
[NCT01814761]312 participants (Actual)Observational2013-05-31Completed
[NCT00907426]Phase 3368 participants (Actual)Interventional2009-08-31Completed
[NCT01863953]Phase 2112 participants (Actual)Interventional2013-06-30Completed
[NCT01068964]235 participants (Actual)Interventional2010-02-01Completed
Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study [NCT04896125]300 participants (Anticipated)Observational2019-10-02Recruiting
An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT) [NCT04285580]Phase 337 participants (Actual)Interventional2020-06-11Completed
[NCT01881126]Phase 493 participants (Actual)Interventional2013-06-30Completed
[NCT00538304]Phase 2222 participants (Actual)Interventional2007-11-30Completed
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, [NCT01216943]Phase 3126 participants (Actual)Interventional2010-11-30Completed
[NCT01976624]756 participants (Actual)Observational2009-08-31Completed
A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocul [NCT01915940]Phase 2169 participants (Actual)Interventional2013-10-23Completed
Assessment of Late Day IOP Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®) [NCT01464424]Phase 484 participants (Actual)Interventional2011-10-31Completed
[NCT01568008]933 participants (Actual)Observational2011-10-31Completed
[NCT01999348]1,553 participants (Actual)Observational2013-11-25Completed
[NCT02097719]Phase 4100 participants (Actual)Interventional2014-05-31Completed
Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure [NCT02448043]45 participants (Actual)Interventional2015-06-04Completed
An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002 [NCT02143843]Phase 275 participants (Actual)Interventional2014-06-05Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00440011 (2) [back to overview]Tolerability - Conjunctival Hyperemia
NCT00440011 (2) [back to overview]Intraocular Pressure (IOP)
NCT00538304 (6) [back to overview]Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
NCT00538304 (6) [back to overview]Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
NCT00538304 (6) [back to overview]Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
NCT00538304 (6) [back to overview]Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
NCT00538304 (6) [back to overview]Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
NCT00538304 (6) [back to overview]Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
NCT00539526 (3) [back to overview]Change From Baseline in Corneal Staining With Fluorescein at Month 3
NCT00539526 (3) [back to overview]Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
NCT00539526 (3) [back to overview]Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
NCT00541242 (2) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
NCT00541242 (2) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
NCT00693420 (10) [back to overview]Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
NCT00693420 (10) [back to overview]Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
NCT00693420 (10) [back to overview]Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
NCT00693420 (10) [back to overview]Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
NCT00693420 (10) [back to overview]Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
NCT00693420 (10) [back to overview]Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
NCT00693420 (10) [back to overview]Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)
NCT00693420 (10) [back to overview]Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
NCT00693420 (10) [back to overview]Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
NCT00693420 (10) [back to overview]Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
NCT00705757 (1) [back to overview]The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.
NCT00716742 (1) [back to overview]Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
NCT00773136 (1) [back to overview]Efficacy of Bimatoprost in Lengthening of Eyelashes
NCT00809848 (2) [back to overview]Change From Baseline in Average Eye Intraocular Pressure (IOP)
NCT00809848 (2) [back to overview]Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
NCT00907426 (5) [back to overview]Percentage of Treatment Responders at Month 4
NCT00907426 (5) [back to overview]Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4
NCT00907426 (5) [back to overview]Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4
NCT00907426 (5) [back to overview]Change From Baseline in Upper Eyelash Length at Month 4
NCT00907426 (5) [back to overview]Change From Baseline in Upper Eyelash Darkness at Month 4
NCT00958035 (1) [back to overview]Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
NCT01001195 (1) [back to overview]Change From Baseline in Average Eye Intraocular Pressure (IOP)
NCT01016691 (1) [back to overview]Mean Change in Intraocular Pressure at Day 1
NCT01023841 (5) [back to overview]Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
NCT01023841 (5) [back to overview]Percentage of Participants With Adverse Events
NCT01023841 (5) [back to overview]Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)
NCT01023841 (5) [back to overview]Change From Baseline in Upper Eyelash Thickness as Measured by DIA
NCT01023841 (5) [back to overview]Change From Baseline in Upper Eyelash Darkness as Measured by DIA
NCT01064882 (7) [back to overview]Treatment Satisfaction Questionnaire Score at Month 3
NCT01064882 (7) [back to overview]Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
NCT01064882 (7) [back to overview]Change From Baseline in Upper Eyelash Thickness at Month 3
NCT01064882 (7) [back to overview]Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
NCT01064882 (7) [back to overview]Change From Baseline in Overall Eyelash Satisfaction at Month 3
NCT01064882 (7) [back to overview]Change From Baseline in Eyelash Length at Month 3
NCT01064882 (7) [back to overview]Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
NCT01068964 (1) [back to overview]The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
NCT01099774 (4) [back to overview]Average Eye IOP at Week 6
NCT01099774 (4) [back to overview]Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
NCT01099774 (4) [back to overview]Average Eye IOP at Week 12
NCT01099774 (4) [back to overview]Average Eye IOP at Week 2
NCT01110499 (2) [back to overview]Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
NCT01110499 (2) [back to overview]Part 1: Change From Baseline in Intraocular Pressure (IOP)
NCT01157364 (4) [back to overview]Time to Rescue Treatment or Re-Treatment in the Study Eye
NCT01157364 (4) [back to overview]Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
NCT01157364 (4) [back to overview]Mean Diurnal IOP in the Study Eye
NCT01157364 (4) [back to overview]Time-Matched Intraocular Pressure (IOP) in the Study Eye
NCT01170884 (1) [back to overview]Mean Diurnal Intraocular Pressure (IOP) at Week 12
NCT01177098 (6) [back to overview]Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
NCT01177098 (6) [back to overview]Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
NCT01177098 (6) [back to overview]Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
NCT01177098 (6) [back to overview]Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
NCT01177098 (6) [back to overview]Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
NCT01177098 (6) [back to overview]Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
NCT01189279 (5) [back to overview]Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
NCT01189279 (5) [back to overview]Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
NCT01189279 (5) [back to overview]Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
NCT01189279 (5) [back to overview]Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
NCT01189279 (5) [back to overview]Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
NCT01216943 (1) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
NCT01217606 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
NCT01217606 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)
NCT01217606 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure
NCT01229423 (6) [back to overview]Change From Baseline in Eyelash Intensity (Darkness) at Week 20
NCT01229423 (6) [back to overview]Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
NCT01229423 (6) [back to overview]Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
NCT01229423 (6) [back to overview]Percentage of Subjects Satisfied With Treatment at Week 20
NCT01229423 (6) [back to overview]Change From Baseline in Eyelash Thickness at Week 20
NCT01229423 (6) [back to overview]Change From Baseline in Eyelash Length at Week 20
NCT01241240 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
NCT01241240 (3) [back to overview]Change From Baseline in Mean Worse Eye IOP
NCT01241240 (3) [back to overview]Mean Worse Eye IOP
NCT01243567 (5) [back to overview]Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
NCT01243567 (5) [back to overview]Change From Baseline in Average Intraocular Pressure (IOP)
NCT01243567 (5) [back to overview]Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
NCT01243567 (5) [back to overview]Change From Baseline IOP
NCT01243567 (5) [back to overview]Percentage of Patients Reaching a Predefined Target Pressure Threshold
NCT01253902 (3) [back to overview]Mean Corneal Staining With Fluorescein at Week 12
NCT01253902 (3) [back to overview]Mean Conjunctival Hyperemia at Week 12
NCT01253902 (3) [back to overview]Mean Tear Break Up Time (TBUT) at Week 12
NCT01263444 (4) [back to overview]Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
NCT01263444 (4) [back to overview]Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
NCT01263444 (4) [back to overview]Mean Change From Baseline in IOP at Week 4
NCT01263444 (4) [back to overview]Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
NCT01271686 (1) [back to overview]Nocturnal Intraocular Pressure (IOP) Change
NCT01291108 (2) [back to overview]Change From Baseline in Average Eye IOP
NCT01291108 (2) [back to overview]Change From Baseline in Worse Eye IOP
NCT01298700 (2) [back to overview]Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
NCT01298700 (2) [back to overview]"Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia"
NCT01325337 (6) [back to overview]Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
NCT01325337 (6) [back to overview]Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
NCT01325337 (6) [back to overview]Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
NCT01325337 (6) [back to overview]Change From Baseline in Target Area Hair Width (TAHW)
NCT01325337 (6) [back to overview]Change From Baseline in Target Area Hair Darkness (TAHD)
NCT01325337 (6) [back to overview]Change From Baseline in Target Area Hair Count (TAHC)
NCT01325350 (6) [back to overview]Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
NCT01325350 (6) [back to overview]Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
NCT01325350 (6) [back to overview]Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
NCT01325350 (6) [back to overview]Change From Baseline in Target Area Hair Width (TAHW)
NCT01325350 (6) [back to overview]Change From Baseline in Target Area Hair Darkness (TAHD)
NCT01325350 (6) [back to overview]Change From Baseline in Target Area Hair Count (TAHC)
NCT01391273 (4) [back to overview]Change From Baseline in Eyelash Thickness as Measured by DIA
NCT01391273 (4) [back to overview]Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
NCT01391273 (4) [back to overview]Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
NCT01391273 (4) [back to overview]Change From Baseline in Eyelash Darkness as Measured by DIA
NCT01391286 (4) [back to overview]Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
NCT01391286 (4) [back to overview]Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
NCT01391286 (4) [back to overview]Change From Baseline in Eyelash Thickness as Measured by DIA
NCT01391286 (4) [back to overview]Change From Baseline in Eyelash Darkness as Measured by DIA
NCT01448525 (2) [back to overview]Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
NCT01448525 (2) [back to overview]Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
NCT01464424 (2) [back to overview]Mean IOP at Each After Office Hour Evaluation Timepoint
NCT01464424 (2) [back to overview]Overall Mean Intraocular Pressure (IOP)
NCT01489670 (7) [back to overview]Physician Reported Reasons for Early Discontinuation of Treatment
NCT01489670 (7) [back to overview]Intraocular Pressure (IOP) at Baseline
NCT01489670 (7) [back to overview]Number of Patients Continuing Treatment After 12 Weeks
NCT01489670 (7) [back to overview]Intraocular Pressure (IOP) at Week 12
NCT01489670 (7) [back to overview]Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale
NCT01489670 (7) [back to overview]Physician Evaluation of Efficacy Using a 5-Point Scale
NCT01489670 (7) [back to overview]Physician Evaluation of Tolerability of Treatment
NCT01525173 (1) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
NCT01547598 (5) [back to overview]Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
NCT01547598 (5) [back to overview]Change From Baseline in Mean IOP at Week 6
NCT01547598 (5) [back to overview]Change From Baseline in Mean IOP at Week 12
NCT01547598 (5) [back to overview]Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
NCT01547598 (5) [back to overview]Mean Diurnal Intraocular Pressure (IOP)
NCT01568008 (6) [back to overview]Physician Reported Reasons for Treatment Discontinuation
NCT01568008 (6) [back to overview]Number of Patients Continuing Treatment After 12 Weeks
NCT01568008 (6) [back to overview]Intraocular Pressure (IOP) at Baseline
NCT01568008 (6) [back to overview]Physician Assessment of Treatment Tolerability Using a 4-Point Scale
NCT01568008 (6) [back to overview]Intraocular Pressure (IOP) at Week 12
NCT01568008 (6) [back to overview]Patient Assessment of Treatment Tolerability Using a 4-Point Scale
NCT01589510 (8) [back to overview]Patient Assessment of Tolerability on a 4-Point Scale
NCT01589510 (8) [back to overview]IOP at Week 14
NCT01589510 (8) [back to overview]Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment
NCT01589510 (8) [back to overview]Intraocular Pressure (IOP) at Baseline
NCT01589510 (8) [back to overview]Physician Evaluation of IOP Lowering in the Study Eye(s)
NCT01589510 (8) [back to overview]Percentage of Patients Who Continue Lumigan® 0.01% Treatment
NCT01589510 (8) [back to overview]Physician Assessment of Tolerability on a 4-Point Scale
NCT01589510 (8) [back to overview]Physician Assessment of Patient Compliance Compared to Previous Therapy
NCT01594970 (4) [back to overview]Change From Baseline in Intraocular Pressure (IOP)
NCT01594970 (4) [back to overview]Overall Percent Change From Baseline in IOP
NCT01594970 (4) [back to overview]Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
NCT01594970 (4) [back to overview]Change From Baseline in Hyperemia Severity in the Study Eye
NCT01623479 (3) [back to overview]Number of Applications of Latisse® Per Week
NCT01623479 (3) [back to overview]Percentage of Subjects Satisfied With Latisse®
NCT01623479 (3) [back to overview]Percentage of Subjects Satisfied Wtih Their Eyelashes
NCT01628588 (5) [back to overview]Patient Assessment of Tolerability Using a 4-Point Scale
NCT01628588 (5) [back to overview]Change From Baseline in Intraocular Pressure (IOP)
NCT01628588 (5) [back to overview]Physician Assessment of Tolerability Using a 4-Point Scale
NCT01628588 (5) [back to overview]Patients Who Will Continue Use of Lumigan® After 14 Weeks
NCT01628588 (5) [back to overview]Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
NCT01628601 (5) [back to overview]Physician Assessment of Tolerability Using a 4-Point Scale
NCT01628601 (5) [back to overview]Physician Assessment of Adherence to GANfort®
NCT01628601 (5) [back to overview]Change From Baseline in Intraocular Pressure (IOP)
NCT01628601 (5) [back to overview]Patients Continuing With GANfort® After 18 Weeks
NCT01628601 (5) [back to overview]Patient Assessment of Tolerability Using a 4-Point Scale
NCT01632423 (5) [back to overview]Physician Assessment of Tolerability Using a 4-Point Scale
NCT01632423 (5) [back to overview]Patients Who Will Continue Use of Lumigan® After 14 Weeks
NCT01632423 (5) [back to overview]Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
NCT01632423 (5) [back to overview]Patient Assessment of Tolerability Using a 4-Point Scale
NCT01632423 (5) [back to overview]Change From Baseline in Intraocular Pressure (IOP)
NCT01646151 (8) [back to overview]Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
NCT01646151 (8) [back to overview]Intraocular Pressure (IOP) at Baseline
NCT01646151 (8) [back to overview]IOP at Week 12
NCT01646151 (8) [back to overview]Patient Assessment of Tolerability on a 4-Point Scale
NCT01646151 (8) [back to overview]Physician Assessment of Patient Compliance Compared to Previous Therapy
NCT01646151 (8) [back to overview]Physician Evaluation of IOP Lowering in the Study Eye(s)
NCT01646151 (8) [back to overview]Physician Assessment of Tolerability on a 4-Point Scale
NCT01646151 (8) [back to overview]Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
NCT01664039 (8) [back to overview]Percentage of Subjects Who Reached Target IOP at Each Visit
NCT01664039 (8) [back to overview]Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
NCT01664039 (8) [back to overview]Mean Change From Baseline in IOP at Week 6 and Month 3
NCT01664039 (8) [back to overview]Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
NCT01664039 (8) [back to overview]Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
NCT01664039 (8) [back to overview]Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
NCT01664039 (8) [back to overview]Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
NCT01664039 (8) [back to overview]Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
NCT01698554 (5) [back to overview]Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
NCT01698554 (5) [back to overview]Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
NCT01698554 (5) [back to overview]Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
NCT01698554 (5) [back to overview]Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
NCT01698554 (5) [back to overview]Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)
NCT01765764 (4) [back to overview]Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
NCT01765764 (4) [back to overview]Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
NCT01765764 (4) [back to overview]Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
NCT01765764 (4) [back to overview]Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
NCT01814761 (4) [back to overview]Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
NCT01814761 (4) [back to overview]Overall Percent Change From Baseline in IOP
NCT01814761 (4) [back to overview]Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
NCT01814761 (4) [back to overview]Percentage of Patients Who Discontinue Due to an Adverse Event
NCT01830140 (1) [back to overview]Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
NCT01833741 (10) [back to overview]Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
NCT01833741 (10) [back to overview]Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
NCT01833741 (10) [back to overview]Percentage of Patients Discontinuing Due to Ocular Adverse Events
NCT01833741 (10) [back to overview]Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
NCT01833741 (10) [back to overview]Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
NCT01833741 (10) [back to overview]Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
NCT01833741 (10) [back to overview]Percentage of Treatment-Naive Patients With Ocular Hyperemia
NCT01833741 (10) [back to overview]Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
NCT01833741 (10) [back to overview]Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
NCT01833741 (10) [back to overview]Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
NCT01853085 (8) [back to overview]Patient Assessment of Tolerability on a 4-Point Scale
NCT01853085 (8) [back to overview]Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
NCT01853085 (8) [back to overview]Number of Patients Who Continue Treatment
NCT01853085 (8) [back to overview]IOP in the Study Eye at Week 12
NCT01853085 (8) [back to overview]Intraocular Pressure (IOP) in the Study Eye at Baseline
NCT01853085 (8) [back to overview]Physician Assessment of Tolerability on a 4-Point Scale
NCT01853085 (8) [back to overview]Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
NCT01853085 (8) [back to overview]Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
NCT01863953 (3) [back to overview]Change From Baseline in Average Eye Mean Diurnal IOP
NCT01863953 (3) [back to overview]Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
NCT01863953 (3) [back to overview]Average Eye Mean Diurnal IOP
NCT01881126 (1) [back to overview]Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
NCT01904721 (6) [back to overview]Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
NCT01904721 (6) [back to overview]Change From Baseline in Target Area Hair Darkness (TAHD)
NCT01904721 (6) [back to overview]Change From Baseline in Target Area Hair Count (TAHC)
NCT01904721 (6) [back to overview]Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
NCT01904721 (6) [back to overview]Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
NCT01904721 (6) [back to overview]Change From Baseline in Target Area Hair Width (TAHW)
NCT01915940 (6) [back to overview]Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
NCT01915940 (6) [back to overview]Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
NCT01915940 (6) [back to overview]Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
NCT01915940 (6) [back to overview]Change From Baseline in IOP at Month 4
NCT01915940 (6) [back to overview]Change From Baseline in IOP at Month 6
NCT01915940 (6) [back to overview]Change From Baseline in IOP at Month 5
NCT01976624 (2) [back to overview]Change From Baseline in Intraocular Pressure (IOP)
NCT01976624 (2) [back to overview]Number of Participants With Adverse Events and Adverse Drug Reactions
NCT01999348 (7) [back to overview]Percentage of Patients Prescribed by the Physician to Continue Treatment
NCT01999348 (7) [back to overview]Percentage of Patients Who Discontinued Treatment
NCT01999348 (7) [back to overview]Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
NCT01999348 (7) [back to overview]Patient Assessment of Tolerability on a 4-Point Scale
NCT01999348 (7) [back to overview]Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
NCT01999348 (7) [back to overview]Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
NCT01999348 (7) [back to overview]Physician Assessment of Tolerability on a 4-Point Scale
NCT02020512 (1) [back to overview]Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
NCT02061683 (2) [back to overview]Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
NCT02061683 (2) [back to overview]Intraocular Pressure (IOP) in the Study Eye
NCT02097719 (1) [back to overview]Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
NCT02143843 (2) [back to overview]Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
NCT02143843 (2) [back to overview]Change From Baseline in Mean Intraocular Pressure (IOP)
NCT02170662 (3) [back to overview]Percent Change in Target Area Total Hair Count
NCT02170662 (3) [back to overview]Percent Change in the Target Area Terminal Hair Count
NCT02170662 (3) [back to overview]Percent Change in the Target Area Vellus Hair Count
NCT02176356 (14) [back to overview]Change From Baseline in Aging Appearance Using a 7-item Questionnaire
NCT02176356 (14) [back to overview]Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)
NCT02176356 (14) [back to overview]Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS
NCT02176356 (14) [back to overview]Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
NCT02176356 (14) [back to overview]Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
NCT02176356 (14) [back to overview]Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
NCT02176356 (14) [back to overview]Change From Baseline in Social Confidence Using an 8-item Questionnaire
NCT02176356 (14) [back to overview]Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
NCT02176356 (14) [back to overview]Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
NCT02176356 (14) [back to overview]Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS
NCT02176356 (14) [back to overview]Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
NCT02176356 (14) [back to overview]Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
NCT02176356 (14) [back to overview]Participant's Self- Perception of Age (SPA)
NCT02176356 (14) [back to overview]Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 2 (Hour 0)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 2 (Hour 2)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 6 (Hour 0)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 6 (Hour 2)
NCT02247804 (8) [back to overview]Change From Baseline in IOP in the Study Eye
NCT02247804 (8) [back to overview]Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 12 (Hour 0)
NCT02247804 (8) [back to overview]IOP in the Study Eye at Week 12 (Hour 2)
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 6 (Hour 2)
NCT02250651 (8) [back to overview]Change From Baseline in IOP in the Study Eye
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 12 (Hour 0)
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 12 (Hour 2)
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 2 (Hour 0)
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 2 (Hour 2)
NCT02250651 (8) [back to overview]IOP in the Study Eye at Week 6 (Hour 0)
NCT02250651 (8) [back to overview]Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
NCT02358369 (13) [back to overview]Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
NCT02358369 (13) [back to overview]Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
NCT02358369 (13) [back to overview]Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
NCT02358369 (13) [back to overview]Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
NCT02358369 (13) [back to overview]Change From Baseline in Automated Visual Field at Week 12
NCT02358369 (13) [back to overview]Change From Baseline in Intraocular Pressure (IOP) at Week 8
NCT02358369 (13) [back to overview]Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
NCT02358369 (13) [back to overview]Change From Baseline in IOP at Week 12
NCT02358369 (13) [back to overview]Change From Baseline in IOP at Week 2
NCT02358369 (13) [back to overview]Change From Baseline in IOP at Week 6
NCT02358369 (13) [back to overview]Change From Baseline in IOP in Period C
NCT02358369 (13) [back to overview]Dilated Fundus Exam: Cup-to-Disc-Ratio
NCT02358369 (13) [back to overview]Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
NCT02419508 (7) [back to overview]Mean Diurnal IOP at Week 6
NCT02419508 (7) [back to overview]Mean Percentage Change From Baseline at 09:00 at Week 6
NCT02419508 (7) [back to overview]Mean Percentage Change From Baseline in Diurnal IOP at Week 6
NCT02419508 (7) [back to overview]Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
NCT02419508 (7) [back to overview]Mean Change From Baseline in IOP at 09:00 at Week 6
NCT02419508 (7) [back to overview]Mean Change From Baseline in IOP at 11:00 at Week 6
NCT02419508 (7) [back to overview]Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
NCT02448043 (5) [back to overview]Number of Days Until the First Nail Chipped
NCT02448043 (5) [back to overview]Intraocular Pressure at 30 Days of Treatment
NCT02448043 (5) [back to overview]Change From Baseline in Nail Length of Hands
NCT02448043 (5) [back to overview]Nail Brittleness at 30 Days of Treatment
NCT02448043 (5) [back to overview]Change From Baseline in Nail Length of Digits
NCT02537015 (1) [back to overview]Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
NCT02636946 (7) [back to overview]Change From Baseline in IOP at Week 12
NCT02636946 (7) [back to overview]Change From Baseline in Intraocular Pressure (IOP) at Week 24
NCT02636946 (7) [back to overview]Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
NCT02636946 (7) [back to overview]Change From Baseline in IOP at Weeks 8, 15, and 20
NCT02636946 (7) [back to overview]Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
NCT02636946 (7) [back to overview]Intraocular Pressure (IOP) at Baseline
NCT02636946 (7) [back to overview]Change From Baseline in IOP at Week 4
NCT02742649 (7) [back to overview]Intraocular Pressure (IOP) on Day 8
NCT02742649 (7) [back to overview]IOP on Day 70
NCT02742649 (7) [back to overview]IOP on Day 49
NCT02742649 (7) [back to overview]IOP on Day 28
NCT02742649 (7) [back to overview]Number of Participants With Ocular and Non-Ocular Adverse Events
NCT02742649 (7) [back to overview]IOP During Open Label Period
NCT02742649 (7) [back to overview]IOP on Day 16
NCT02830776 (2) [back to overview]Change in Patient Satisfaction
NCT02830776 (2) [back to overview]Graded Change in Dermatochalasis
NCT03825380 (1) [back to overview]Intra-Ocular Pressure
NCT04285580 (3) [back to overview]Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
NCT04285580 (3) [back to overview]Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
NCT04285580 (3) [back to overview]Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes

Tolerability - Conjunctival Hyperemia

Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) (NCT00440011)
Timeframe: Month 3

Interventionparticipants (Number)
Bimatoprost15
Travoprost22

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Intraocular Pressure (IOP)

Intraocular Pressure (NCT00440011)
Timeframe: Month 3

Interventionmm Hg (Mean)
Bimatoprost17
Travoprost17.5

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Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1

Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness. (NCT00538304)
Timeframe: Baseline, Month 1

,
InterventionNumber on a scale (score) (Mean)
BaselineMonth 1
Bimatoprost Eye Drops0.320.18
Placebo0.300.02

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Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1

Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). (NCT00538304)
Timeframe: Month 1

InterventionPercentage of Patients (Number)
Bimatoprost Eye Drops8.16
Placebo1.41

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Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1

"Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason." (NCT00538304)
Timeframe: Month 1

InterventionPercentage of Physicians (Number)
Bimatoprost Eye Drops85.7
Placebo39.5

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Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1

Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. (NCT00538304)
Timeframe: Baseline, Month 1

,
Interventionmillimeters of mercury (mmHg) (Mean)
Baseline, 8AMMonth 1, 8AM
Bimatoprost Eye Drops18.2-1.0
Placebo18.03.6

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Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1

"Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason." (NCT00538304)
Timeframe: Month 1

InterventionPercentage of Patients (Number)
Bimatoprost Eye Drops88.5
Placebo52.9

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Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1

"Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect." (NCT00538304)
Timeframe: Month 1

InterventionPercentage of Patients (Number)
Bimatoprost Eye Drops95.1
Placebo94.1

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Change From Baseline in Corneal Staining With Fluorescein at Month 3

Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement. (NCT00539526)
Timeframe: Baseline, Month 3

,,
InterventionScores on a Scale (Mean)
BaselineMonth 3
Bimatoprost 0.03%0.590.15
Latanoprost 0.005%0.70-0.18
Travoprost 0.004%0.48-0.07

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Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3

Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement. (NCT00539526)
Timeframe: Baseline, Month 3

,,
InterventionScores on Scale (Mean)
BaselineMonth 3
Bimatoprost 0.03%0.740.05
Latanoprost 0.005%0.740.06
Travoprost 0.004%0.860.07

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Change From Baseline in Tear Break-Up Time (TBUT) at Month 3

Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. (NCT00539526)
Timeframe: Baseline, Month 3

,,
InterventionSeconds (Mean)
BaselineMonth 3
Bimatoprost 0.03%9.10.5
Latanoprost 0.005%8.60.4
Travoprost 0.004%7.91.7

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Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18

Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. (NCT00541242)
Timeframe: Baseline, Week 18

,
Interventionmillimeters of mercury (mmHg) (Mean)
BaselineWeek 18
Bimatoprost 0.03% Eye Drops21.90-5.77
Latanoprost 0.005% Eye Drops22.16-5.09

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Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12

Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. (NCT00541242)
Timeframe: Baseline, Week 12

,
Interventionmillimeters of mercury (mmHg) (Mean)
BaselineWeek 12
Bimatoprost 0.03% Eye Drops21.90-5.64
Latanoprost 0.005% Eye Drops22.16-4.89

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Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16

"Overall, how satisfied are you with your eyelashes?~Possible Answers on a 5 point scale as follows:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied" (NCT00693420)
Timeframe: Baseline to Week 16

,
Interventionscore on a scale (Mean)
Day 1 (Baseline)Week 1Week 4Week 8Week 12Week 16 (Primary Endpoint)
Bimatoprost 0.03% Solution4.180.06-0.25-0.90-1.48-1.89
Vehicle Solution4.16-0.06-0.35-0.57-0.67-0.70

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Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16

The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) (NCT00693420)
Timeframe: Baseline to Week 16

,
InterventionPercentage of participants (Number)
Week 1Week 4Week 8Week 12Week 16 (Primary Endpoint)
Bimatoprost 0.03% Solution5.114.650.469.378.1
Vehicle Solution2.17.814.919.918.4

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Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) (NCT00693420)
Timeframe: Baseline to Week 16

,
Interventionintensity unit (Mean)
Day 1 (Baseline)Week 1Week 4Week 8Week 12Week 16 (Primary Endpoint)
Bimatoprost 0.03% Solution105.67-2.97-5.10-9.11-16.68-20.15
Vehicle Solution102.82-1.25-2.91-2.46-4.22-3.57

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Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

Upper eyelash length technologically measured in millimeters (NCT00693420)
Timeframe: Baseline to Week 16

,
Interventionmillimeters (Mean)
Day 1 (Baseline)Week 1Week 4Week 8Week 12Week 16 (Primary Endpoint)
Bimatoprost 0.03% Solution5.790.050.220.641.161.39
Vehicle Solution5.710.000.060.070.050.11

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Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. (NCT00693420)
Timeframe: Baseline to Week 16

,
Interventionpercentage of AOI (in pixels) (Mean)
Day 1 (Baseline)Week 1Week 4Week 8Week 12Week 16 (Primary Endpoint)
Bimatoprost 0.03% Solution16.160.941.623.489.3012.21
Vehicle Solution16.660.240.810.750.951.10

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Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)

The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) (NCT00693420)
Timeframe: Baseline to Week 20

InterventionPercentage of participants (Number)
Bimatoprost 0.03% Solution78.6
Vehicle Solution21.4

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Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)

"Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)" (NCT00693420)
Timeframe: Baseline to Week 20

Interventionscore on a scale (Mean)
Bimatoprost 0.03% Solution-2.06
Vehicle Solution-0.61

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Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)

Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) (NCT00693420)
Timeframe: Baseline to Week 20

Interventionintensity unit (Mean)
Bimatoprost 0.03% Solution-20.12
Vehicle Solution-5.51

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Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)

Upper eyelash length technologically measured in millimeters (NCT00693420)
Timeframe: Baseline to Week 20

Interventionmillimeters (Mean)
Bimatoprost 0.03% Solution1.47
Vehicle Solution0.06

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Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)

Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. (NCT00693420)
Timeframe: Baseline to Week 20

Interventionpercentage of AOI (in pixels) (Mean)
Bimatoprost 0.03% Solution11.16
Vehicle Solution1.88

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The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.

"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.~Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement." (NCT00705757)
Timeframe: one year

,,
InterventionL*a*b* (Mean)
Upper LidLower LidCheek/Face
Lumigan-0.90-0.370.30
Travatan-0.900.170.51
Xalatan-1.420.480.55

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Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year

Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement). (NCT00716742)
Timeframe: Baseline, 1 Year

,,
InterventionMillimeters of mercury (mmHg) (Mean)
BaselineChange from Baseline at 1 Year
Lumigan®20.8-4.8
Travatan®20.3-4.3
Xalatan®20.6-4.3

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Efficacy of Bimatoprost in Lengthening of Eyelashes

Eyelash growth after application of bimatoprost vs control (split face study). (NCT00773136)
Timeframe: 4.5 months (6 weeks of drug application and 3 months after discontinuing)

Interventionmm (Mean)
Bimatoprost Mixed With Gonak Into a Gel Suspension2
Control Group1.1

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Change From Baseline in Average Eye Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). (NCT00809848)
Timeframe: Baseline, Day 14 Hour 0

,,,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Change from Baseline at Day 14 - Hour 0
AGN-210669 Ophthalmic Solution, 0.025%25.341-4.068
AGN-210669 Ophthalmic Solution, 0.05%25.318-5.197
AGN-210669 Ophthalmic Solution, 0.075%25.350-5.807
AGN-210669 Vehicle Ophthalmic Solution25.507-2.382
Bimatoprost Ophthalmic Solution 0.03%24.650-6.575

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Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day. (NCT00809848)
Timeframe: Baseline, Day 14

InterventionPercentage of Patients (Number)
AGN 210669 Non-preserved Ophthalmic Solution, 0.075%62.9
AGN-210669 Ophthalmic Solution, 0.05%57.6
AGN-210669 Ophthalmic Solution, 0.025%30.3
Bimatoprost Ophthalmic Solution 0.03%63.3
AGN-210669 Vehicle Ophthalmic Solution2.8

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Percentage of Treatment Responders at Month 4

Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15. (NCT00907426)
Timeframe: Month 4

InterventionPercentage of Subjects (Number)
Bimatoprost 0.03%39.3
Vehicle10.9

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Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4

Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. (NCT00907426)
Timeframe: Baseline, Month 4

,
InterventionMillimeters squared (mm^2) (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost 0.03%0.670.59
Vehicle0.82-0.07

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Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4

Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. (NCT00907426)
Timeframe: Month 4

InterventionPercentage of Participants (Number)
Bimatoprost 0.03%73.8
Vehicle28.3

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Change From Baseline in Upper Eyelash Length at Month 4

Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length. (NCT00907426)
Timeframe: Baseline, Month 4

,
InterventionMillimeters (mm) (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost 0.03%5.401.33
Vehicle5.420.07

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Change From Baseline in Upper Eyelash Darkness at Month 4

Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening. (NCT00907426)
Timeframe: Baseline, Month 4

,
InterventionEyelash Intensity Units (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost 0.03%151.36-23.55
Vehicle148.82-2.60

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Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4

Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence). (NCT00958035)
Timeframe: Month 4

InterventionPercentage of Patients (Number)
LATISSE®69.6
Placebo48.8

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Change From Baseline in Average Eye Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). (NCT01001195)
Timeframe: Baseline, Day 29 Hour 0

,,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Change from Baseline at Day 29 - Hour 0
AGN-210669 Ophthalmic Solution, 0.05%25.39-5.66
AGN-210669 Ophthalmic Solution, 0.075%25.18-7.65
AGN-210669 Ophthalmic Solution, 0.1%25.88-7.50
Bimatoprost Ophthalmic Solution 0.03%25.73-8.57

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Mean Change in Intraocular Pressure at Day 1

(NCT01016691)
Timeframe: Baseline to Day 1

InterventionmmHg (Mean)
High Dose Drug Device/ Bimatoprost 0.03%-4.16
Low Dose Drug Device / Bimatoprost 0.03%-4.57
Placebo Device / Bimatoprost 0.03%-0.60

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Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score

The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement. (NCT01023841)
Timeframe: Baseline, Month 4

InterventionPercentage of participants (Number)
Bimatoprost Ophthalmic Solution 0.03%70.8
Vehicle Sterile Solution26.1

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Percentage of Participants With Adverse Events

An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. (NCT01023841)
Timeframe: 5 Months

InterventionPercentage of participants (Number)
Bimatoprost Ophthalmic Solution 0.03%35.4
Vehicle Sterile Solution43.5

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Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)

Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement). (NCT01023841)
Timeframe: Baseline, Month 4

,
Interventionmm (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Ophthalmic Solution 0.03%6.831.12
Vehicle Sterile Solution6.040.67

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Change From Baseline in Upper Eyelash Thickness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement). (NCT01023841)
Timeframe: Baseline, Month 4

,
Interventionmm^2 (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Ophthalmic Solution 0.03%1.200.41
Vehicle Sterile Solution1.180.05

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Change From Baseline in Upper Eyelash Darkness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). (NCT01023841)
Timeframe: Baseline, Month 4

,
InterventionIntensity units (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Ophthalmic Solution 0.03%143.78-15.34
Vehicle Sterile Solution143.44-5.47

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Treatment Satisfaction Questionnaire Score at Month 3

The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best). (NCT01064882)
Timeframe: Month 3

,,
InterventionScores on a Scale (Mean)
If Avail, How Likely Would You Continue to Use It?If Avail, How Likely Would You Recommend It?
Bimatoprost Ophthalmic Solution 0.005%4.14.1
Bimatoprost Ophthalmic Solution 0.015%4.24.2
Bimatoprost Ophthalmic Solution 0.03%4.14.4

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Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3

Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening. (NCT01064882)
Timeframe: Baseline, Month 3

,,
InterventionUnits on a Scale (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost Ophthalmic Solution 0.005%157.14-18.75
Bimatoprost Ophthalmic Solution 0.015%154.41-26.55
Bimatoprost Ophthalmic Solution 0.03%162.41-29.61

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Change From Baseline in Upper Eyelash Thickness at Month 3

Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. (NCT01064882)
Timeframe: Baseline, Month 3

,,
InterventionMillimeters squared (mm^2) (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost Ophthalmic Solution 0.005%12.754.50
Bimatoprost Ophthalmic Solution 0.015%14.675.64
Bimatoprost Ophthalmic Solution 0.03%13.698.48

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Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3

Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline. (NCT01064882)
Timeframe: Baseline, Month 3

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost Ophthalmic Solution 0.005%4.332.79
Bimatoprost Ophthalmic Solution 0.015%4.534.72
Bimatoprost Ophthalmic Solution 0.03%4.943.06

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Change From Baseline in Overall Eyelash Satisfaction at Month 3

"Change from baseline at Month 3 in question 3 overall, how satisfied are you with your eyelashes? Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline." (NCT01064882)
Timeframe: Baseline, Month 3

,,
InterventionScores on a Scale (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost Ophthalmic Solution 0.005%1.471.35
Bimatoprost Ophthalmic Solution 0.015%1.562.25
Bimatoprost Ophthalmic Solution 0.03%1.712.06

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Change From Baseline in Eyelash Length at Month 3

Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length. (NCT01064882)
Timeframe: Baseline, Month 3

,,
Interventionmillimeters (mm) (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost Ophthalmic Solution 0.005%5.650.74
Bimatoprost Ophthalmic Solution 0.015%5.680.92
Bimatoprost Ophthalmic Solution 0.03%5.951.36

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Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3

Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3. (NCT01064882)
Timeframe: Month 3

InterventionPercentage of Subjects (Number)
Bimatoprost Ophthalmic Solution 0.005%52.8
Bimatoprost Ophthalmic Solution 0.015%79.4
Bimatoprost Ophthalmic Solution 0.03%85.3

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The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4

The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section. (NCT01068964)
Timeframe: Baseline, Week 4

,
InterventionMillimeters of mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 4
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles24.87-8.93
0.03% Bimatoprost/0.5% Timolol in Same Bottle25.20-9.38

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Average Eye IOP at Week 6

Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. (NCT01099774)
Timeframe: Week 6

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Week 6 Hour 0Week 6 Hour 2Week 6 Hour 8
Bimatoprost 0.03% Formulation B Ophthalmic Solution17.1616.5216.56
Bimatoprost 0.03% Ophthalmic Solution17.0816.4516.32

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Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. (NCT01099774)
Timeframe: Baseline, Week 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline Hour 0Baseline Hour 2Baseline Hour 8Change from Baseline Hour 0 at Week 12Change from Baseline Hour 2 at Week 12Change from Baseline Hour 8 at Week 12
Bimatoprost 0.03% Formulation B Ophthalmic Solution24.9023.7922.81-7.49-7.06-5.93
Bimatoprost 0.03% Ophthalmic Solution24.8623.7822.80-7.77-7.11-6.06

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Average Eye IOP at Week 12

Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. (NCT01099774)
Timeframe: Baseline, Week 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline Hour 0Baseline Hour 2Baseline Hour 8Week 12 Hour 0Week 12 Hour 2Week 12 Hour 8
Bimatoprost 0.03% Formulation B Ophthalmic Solution24.5323.3022.3117.2516.5116.64
Bimatoprost 0.03% Ophthalmic Solution24.4623.2622.2916.9616.5516.59

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Average Eye IOP at Week 2

Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. (NCT01099774)
Timeframe: Week 2

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Week 2 Hour 0Week 2 Hour 2Week 2 Hour 8
Bimatoprost 0.03% Formulation B Ophthalmic Solution17.4016.6816.61
Bimatoprost 0.03% Ophthalmic Solution17.1416.4316.39

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Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12. (NCT01110499)
Timeframe: Baseline, Day 29

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Baseline - Hour 2Baseline - Hour 4Baseline - Hour 6Baseline - Hour 8Baseline - Hour 12Change from Baseline at Day 29 - Hour 0Change from Baseline at Day 29 - Hour 2Change from Baseline at Day 29 - Hour 4Change from Baseline at Day 29 - Hour 6Change from Baseline at Day 29 - Hour 8Change from Baseline at Day 29 - Hour 12
Part 2, AGN-210961 Formulation 724.6323.4022.2521.9721.2820.72-7.44-7.40-6.25-6.31-6.15-5.74
Part 2, Bimatoprost Ophthalmic Solution 0.03%24.6223.7022.5122.3821.4820.94-8.63-8.51-7.39-6.92-6.31-5.10

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Part 1: Change From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups. (NCT01110499)
Timeframe: Baseline, Day 7

,,,,,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Baseline - Hour 2Baseline - Hour 4Baseline - Hour 6Baseline - Hour 8Baseline - Hour 12Change from Baseline at Day 7- Hour 0Change from Baseline at Day 7- Hour 2Change from Baseline at Day 7- Hour 4Change from Baseline at Day 7 - Hour 6Change from Baseline at Day 7- Hour 8Change from Baseline at Day 7- Hour 12
Part 1, AGN-210961 Formulation 125.423.123.522.021.622.1-6.1-5.3-6.6-5.6-5.9-5.4
Part 1, AGN-210961 Formulation 225.623.523.122.021.321.6-6.3-6.6-4.5-4.5-4.8-4.9
Part 1, AGN-210961 Formulation 324.323.623.624.423.221.8-5.9-6.0-6.3-6.7-5.8-4.8
Part 1, AGN-210961 Formulation 426.723.623.021.922.121.6-6.0-5.6-4.0-3.2-4.4-4.8
Part 1, AGN-210961 Formulation 524.423.123.122.122.221.3-5.2-5.3-5.2-5.1-5.5-3.7
Part 1, AGN-210961 Formulation 625.324.123.722.422.920.8-5.6-5.2-5.2-4.7-4.9-3.7
Part 1, Bimatoprost Ophthalmic Solution 0.03%25.323.423.222.522.321.5-6.3-5.0-5.1-5.5-6.2-5.6

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Time to Rescue Treatment or Re-Treatment in the Study Eye

Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye. (NCT01157364)
Timeframe: 24 Months

InterventionDays (Median)
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%328
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%265
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%273
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%391.5
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%411
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%237

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Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT01157364)
Timeframe: Baseline, Month 24

,,,,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline Hour 0,Week 4, Hour 0Week 12, Hour 0Month 6, Hour 0Month 12, Hour 0Month 18, Hour 0Month 24, Hour 0
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%24.22-7.33-7.00-5.40-5.71-9.75-5.50
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%24.48-7.18-6.82-5.38-6.00-7.70-7.40
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%23.73-5.50-5.95-3.94-5.80-4.25-8.50
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%25.14-7.80-7.02-6.50-5.64-6.92-7.30
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%26.57-8.83-7.92-5.65-9.00-6.00-5.75
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%25.14-7.09-6.53-6.81-5.38-6.93-5.70

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Mean Diurnal IOP in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP. (NCT01157364)
Timeframe: Baseline, Month 6

,,,,,
InterventionmmHg (Mean)
BaselineWeek 4Week 12Month 6
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%22.0916.8817.0618.55
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%23.0216.4017.3318.94
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%20.8417.8917.1218.13
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%23.7416.5918.2218.51
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%23.3817.1017.3419.79
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%23.5417.3517.2916.71

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Time-Matched Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. (NCT01157364)
Timeframe: Baseline to Month 6

,,,,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline, Hour 0Week 4, Hour 0Week 12, Hour 0Month 6, Hour 0
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%24.2217.0017.2318.80
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%24.4817.5517.6119.35
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%23.7318.2317.7719.44
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%25.1417.4518.1217.90
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%26.5717.7317.7119.10
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%25.1417.5318.0317.35

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Mean Diurnal Intraocular Pressure (IOP) at Week 12

Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye. (NCT01170884)
Timeframe: Week 12

InterventionMillimeters of mercury (mm Hg) (Mean)
Combigan® + Lumigan®15.4
Lumigan®19.2

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Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8. (NCT01177098)
Timeframe: Week 12

,
Interventionmm Hg (Mean)
Week 12_Hour 0Week 12_Hour 2Week 12_Hour 8
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution16.5616.3716.09
Bimatoprost/Timolol Formulation A16.2916.1815.85

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Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). (NCT01177098)
Timeframe: Baseline, Week 12

,
Interventionmm Hg (Mean)
Baseline_Hour 0Baseline_Hour 2Baseline_Hour 8Change from baseline at Week 12_Hour 0Change from baseline at Week 12_Hour 2Change from baseline at Week 12_Hour 8
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution25.3024.6123.80-8.51-8.08-7.52
Bimatoprost/Timolol Formulation A25.3424.7123.81-8.94-8.44-7.87

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Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement). (NCT01177098)
Timeframe: Baseline, Week 12

,
Interventionmm Hg (Mean)
Baseline_Hour 0Baseline_Hour 2Baseline_Hour 8Change from baseline at Week 12_Hour 0Change from baseline at Week 12_Hour 2Change from baseline at Week 12_Hour 8
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution24.8624.2323.36-8.30-7.86-7.27
Bimatoprost/Timolol Formulation A24.9424.2923.42-8.65-8.11-7.57

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Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8. (NCT01177098)
Timeframe: Week 6

,
Interventionmm Hg (Mean)
Week 6_Hour 0Week 6_Hour 2Week 6_Hour 8
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution16.3116.1715.82
Bimatoprost/Timolol Formulation A16.2815.9015.71

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Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8. (NCT01177098)
Timeframe: Week 2

,
Interventionmm Hg (Mean)
Week 2_Hour 0Week 2_Hour 2Week 2_Hour 8
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution16.4916.2315.83
Bimatoprost/Timolol Formulation A16.2316.0515.49

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Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). (NCT01177098)
Timeframe: Baseline, Week 12

,
Interventionmm Hg (Mean)
Baseline_Hour 0Baseline_Hour 2 (n=255,260)Baseline_Hour 8 (n=254,259)Change from baseline at Week 12_Hour 0 (n=244,237)Change from baseline at Week 12_Hour 2 (n=235,235)Change from baseline at Week 12_Hour 8 (n=237,234)
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution25.3824.7223.82-8.72-8.38-7.72
Bimatoprost/Timolol Formulation A25.4124.7923.88-9.06-8.53-7.98

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Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost

Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. (NCT01189279)
Timeframe: 17 Days

InterventionPicograms/Milliliter (pg/mL) (Mean)
Part 1: Bimatoprost Formulation A1.26
Part 1: Bimatoprost Formulation B3.01
Part 2: Bimatoprost Formulation C10.1

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Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings

An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm. (NCT01189279)
Timeframe: 17 Days

InterventionPercentage of Patients (Number)
Part 1: Bimatoprost Formulation A0.0
Part 1: Bimatoprost Formulation B0.0
Part 2: Bimatoprost Formulation C0.0

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Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment

Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms. (NCT01189279)
Timeframe: Baseline, 20 Days

,,
InterventionPatients (Number)
Dryness/ScalingEdemaErythemaFolliculitisPigmentation
Part 1: Bimatoprost Formulation A00410
Part 1: Bimatoprost Formulation B10000
Part 2: Bimatoprost Formulation C00000

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Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment

Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms. (NCT01189279)
Timeframe: Baseline, 20 Days

,,
InterventionPatients (Number)
BurningItchingStinging
Part 1: Bimatoprost Formulation A010
Part 1: Bimatoprost Formulation B000
Part 2: Bimatoprost Formulation C010

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Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost

Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. (NCT01189279)
Timeframe: Day 1

InterventionPicograms/Milliliter (pg/mL) (Mean)
Part 1: Bimatoprost Formulation A0.552
Part 1: Bimatoprost Formulation B1.77
Part 2: Bimatoprost Formulation C5.58

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Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). (NCT01216943)
Timeframe: Baseline, Week 12

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 12
Triple Combination Therapy22.35-3.98

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Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test. (NCT01217606)
Timeframe: Baseline, Week 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 12 (N=85, 93)
Combigan®24.43-8.28
Triple Combination Therapy25.42-10.45

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Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA. (NCT01217606)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 1 (N=82, 91)Change from Baseline at Week 2 (N=84, 92)Change from Baseline at Week 4 (N=85, 93)Change from Baseline at Week 8 (N=85, 93)Change from Baseline at Week 12 (N=85, 93)Change from Baseline at Month 6 (N=67, 73)Change from Baseline at Month 9 (N=67, 73)Change from Baseline at Month 12 (N=67, 73)
Combigan®24.43-8.13-8.28-8.53-8.07-8.28-8.42-8.17-7.77
Triple Combination Therapy25.42-11.63-11.20-10.85-10.44-10.45-10.32-10.09-9.36

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Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by a mixed-effect model for repeated measure. (NCT01217606)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 1 (N=82, 91)Change from Baseline at Week 2 (N=82, 87)Change from Baseline at Week 4 (N=82, 88)Change from Baseline at Week 8 (N=75, 87)Change from Baseline at Week 12 (N=76, 83)Change from Baseline at Month 6 (N=64, 69)Change from Baseline at Month 9 (N=58, 67)Change from Baseline at Month 12 (N=55, 63)
Combigan®24.43-8.13-8.12-8.35-7.94-8.16-8.29-8.14-7.58
Triple Combination Therapy25.42-11.63-11.24-10.88-10.53-10.56-10.41-10.29-9.38

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Change From Baseline in Eyelash Intensity (Darkness) at Week 20

Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color. (NCT01229423)
Timeframe: Baseline, Week 20

InterventionUnits on a Scale (Mean)
BaselineChange from Baseline at Week 20
LATISSE®140.02-12.97

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Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20

Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. (NCT01229423)
Timeframe: Week 20

InterventionPercentage of Subjects (Number)
LATISSE®81.4

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Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20

"Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question Overall how satisfied are you with your eyelashes? Responses were based on a 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied). Improvement in subject satisfaction is defined as a 1-point increase from baseline." (NCT01229423)
Timeframe: Week 20

InterventionPercentage of Subjects (Number)
LATISSE®83.05

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Percentage of Subjects Satisfied With Treatment at Week 20

"Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question Which best describes your satisfaction with LATISSE®? Responses were very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. Satisfied is defined as responses of very satisfied and satisfied." (NCT01229423)
Timeframe: Week 20

InterventionPercentage of Subjects (Number)
LATISSE®83.1

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Change From Baseline in Eyelash Thickness at Week 20

Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness. (NCT01229423)
Timeframe: Baseline, Week 20

InterventionMillimeters Squared (mm^2) (Mean)
BaselineChange from Baseline at Week 20
LATISSE®1.390.25

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Change From Baseline in Eyelash Length at Week 20

Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length. (NCT01229423)
Timeframe: Baseline, Week 20

InterventionMillimeter (mm) (Mean)
BaselineChange from Baseline at Week 20
LATISSE®5.921.10

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Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement. (NCT01241240)
Timeframe: Baseline, Week 12

,
InterventionmmHg (Mean)
Baseline (n=93,95)Change from Baseline at Week 12 (n=93,94)
Combigan®25.12-9.18
Triple Combination Therapy24.62-10.03

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Change From Baseline in Mean Worse Eye IOP

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement. (NCT01241240)
Timeframe: Baseline, Weeks 1, 2, 4 and 8

,
InterventionmmHg (Mean)
Baseline (n=93,95)Change from Baseline at Week 1 (n=91,89)Change from Baseline at Week 2 (n=88,93)Change from Baseline at Week 4 (n=86,90)Change from Baseline at Week 8 (n=88,89)
Combigan®25.12-8.90-9.06-9.21-9.02
Triple Combination Therapy24.62-10.18-10.40-10.06-9.77

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Mean Worse Eye IOP

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point. (NCT01241240)
Timeframe: Weeks 1, 2, 4, 8 and 12

,
InterventionmmHg (Mean)
Week 1 (n=91,90)Week 2 (n=88,95)Week 4 (n=86,92)Week 8 (n=88,91)Week 12 (n=86,88)
Combigan®16.2316.0815.9616.1115.92
Triple Combination Therapy14.4314.0514.3814.6814.43

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Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference. (NCT01243567)
Timeframe: Baseline, Month 3

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineAbsolute Difference at Month 3
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution26.2-11.8
Latanoprost 0.005% Ophthalmic Solution26.5-9.9

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Change From Baseline in Average Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement). (NCT01243567)
Timeframe: Baseline, Month 3

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Month 3
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution28.4-13.5
Latanoprost 0.005% Ophthalmic Solution28.5-11.4

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Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference. (NCT01243567)
Timeframe: Baseline, Month 3

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineAbsolute Difference at Month 3
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution30.4-15.3
Latanoprost 0.005% Ophthalmic Solution30.3-12.9

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Change From Baseline IOP

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement). (NCT01243567)
Timeframe: Baseline, Month 3

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline-08:00Baseline-12:00Baseline-16:00Change from Baseline at Month 3-08:00Change from Baseline at Month 3-12:00Change from Baseline at Month 3-16:00
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution29.728.726.8-14.6-13.6-12.4
Latanoprost 0.005% Ophthalmic Solution29.629.026.8-12.3-11.8-10.3

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Percentage of Patients Reaching a Predefined Target Pressure Threshold

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline. (NCT01243567)
Timeframe: Baseline, Month 3

,
InterventionPercentage of Patients (Number)
Decrease of at Least 20%Decrease of at Least 30%Decrease of at Least 40%Decrease of at Least 50%
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution97.790.774.446.5
Latanoprost 0.005% Ophthalmic Solution100.086.847.415.8

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Mean Corneal Staining With Fluorescein at Week 12

Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count). (NCT01253902)
Timeframe: Week 12

InterventionScore on a scale (Mean)
Bimatoprost Ophthalmic Solution 0.01%0.31
Travoprost Ophthalmic Solution 0.004%0.32
Latanoprost Ophthalmic Solution 0.005%0.22

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Mean Conjunctival Hyperemia at Week 12

Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). (NCT01253902)
Timeframe: Week 12

InterventionScore on a scale (Mean)
Bimatoprost Ophthalmic Solution 0.01%0.42
Travoprost Ophthalmic Solution 0.004%0.46
Latanoprost Ophthalmic Solution 0.005%0.44

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Mean Tear Break Up Time (TBUT) at Week 12

Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. (NCT01253902)
Timeframe: Week 12

InterventionSeconds (Mean)
Bimatoprost Ophthalmic Solution 0.01%9.7
Travoprost Ophthalmic Solution 0.004%9.7
Latanoprost Ophthalmic Solution 0.005%9.3

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Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean. (NCT01263444)
Timeframe: Baseline, Week 12

InterventionmmHg (Mean)
AZARGA + Latanoprost (n=22)AZARGA + Travoprost (n=15)
Azarga-7.1-5.1

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Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed. (NCT01263444)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Azarga70.0

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Mean Change From Baseline in IOP at Week 4

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean. (NCT01263444)
Timeframe: Baseline, Week 4

InterventionmmHg (Mean)
Azarga-6.0

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Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean. (NCT01263444)
Timeframe: Baseline, Week 12

InterventionmmHg (Mean)
Azarga-6.0

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Nocturnal Intraocular Pressure (IOP) Change

Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline. (NCT01271686)
Timeframe: 4 weeks

InterventionmmHg (Mean)
0.01% Bimatoprost-2.6

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Change From Baseline in Average Eye IOP

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. (NCT01291108)
Timeframe: Baseline, Day 57

,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Baseline - Hour 4Baseline - Hour 8Baseline - Hour 12Change from Baseline at Day 57-Hr 0 (n=24,25,72)Change from Baseline at Day 57-Hr 4 (n=24,25,72)Change from Baseline at Day 57-Hr 8 (n=24,25,72)Change from Baseline at Day 57-Hr 12 (n=16,17,56)
AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle26.1623.9122.4921.48-7.57-6.95-5.57-5.31
Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle25.9823.8222.3522.07-10.28-8.95-7.19-6.87
Combined Adjunctives26.2623.8522.7921.73-10.84-8.79-7.67-6.03

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Change From Baseline in Worse Eye IOP

IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. (NCT01291108)
Timeframe: Baseline, Day 57

,,
InterventionMillimeters of Mercury (mmHg) (Mean)
Baseline - Hour 0Baseline - Hour 4Baseline - Hour 8Baseline - Hour 12Change from Baseline at Day 57-Hr 0 (n=24,25,72)Change from Baseline at Day 57-Hr 4 (n=24,25,72)Change from Baseline at Day 57-Hr 8 (n=24,25,72)Change from Baseline at Day 57-Hr 12 (n=16,17,56)
AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle26.5624.6023.0421.72-7.50-7.38-5.94-5.00
Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle26.4024.2522.7322.47-10.56-9.16-7.42-7.00
Combined Adjunctives26.6124.3123.1721.93-10.96-9.01-7.92-5.99

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"Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia"

An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported. (NCT01298700)
Timeframe: 24 Months

Interventionpercentage of participants (Number)
Bimatoprost 0.01% Ophthalmic Solution26.0
Bimatoprost 0.03% Ophthalmic Solution29.6

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Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A0.012.129.348.310.30.00.0
Bimatoprost Formulation B5.16.828.855.93.40.00.0
Bimatoprost Formulation C0.04.923.063.98.20.00.0
Minoxidil 5% Solution8.624.115.544.86.90.00.0
Vehicle to Bimatoprost0.06.925.963.83.40.00.0

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Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A0.08.631.043.113.83.40.0
Bimatoprost Formulation B1.711.923.740.715.35.11.7
Bimatoprost Formulation C0.011.716.741.720.06.73.3
Minoxidil 5% Solution5.227.634.522.48.61.70.0
Vehicle to Bimatoprost1.76.919.051.719.01.70.0

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Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A0.03.517.571.97.00.00.0
Bimatoprost Formulation B0.01.810.773.214.30.00.0
Bimatoprost Formulation C0.00.08.674.117.20.00.0
Minoxidil 5% Solution0.05.239.750.03.41.70.0
Vehicle to Bimatoprost0.00.08.975.016.10.00.0

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Change From Baseline in Target Area Hair Width (TAHW)

Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
Interventionmm/cm^2 (Mean)
BaselineChange from Baseline at Month 6
Bimatoprost Formulation A7.830.76
Bimatoprost Formulation B8.340.25
Bimatoprost Formulation C8.590.12
Minoxidil 5% Solution7.821.29
Vehicle to Bimatoprost8.350.13

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Change From Baseline in Target Area Hair Darkness (TAHD)

Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs). (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
InterventionIntensity units (Mean)
BaselineChange from Baseline at Month 6
Bimatoprost Formulation A106.881.19
Bimatoprost Formulation B103.852.92
Bimatoprost Formulation C100.814.04
Minoxidil 5% Solution99.573.40
Vehicle to Bimatoprost104.030.65

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Change From Baseline in Target Area Hair Count (TAHC)

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). (NCT01325337)
Timeframe: Baseline, Month 6

,,,,
Interventionterminal hairs/cm^2 (Mean)
BaselineChange from Baseline at Month 6
Bimatoprost Formulation A135.013.1
Bimatoprost Formulation B145.76.1
Bimatoprost Formulation C151.56.3
Minoxidil 5% Solution132.721.9
Vehicle to Bimatoprost143.74.1

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Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A3.417.234.520.719.01.73.4
Bimatoprost Formulation B3.320.021.733.311.78.31.7
Bimatoprost Formulation C9.316.716.738.913.05.60.0
Minoxidil 2% Solution7.128.635.719.65.41.81.8
Vehicle to Bimatoprost3.318.024.629.513.18.23.3

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Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A5.212.124.139.715.53.40.0
Bimatoprost Formulation B3.310.035.040.010.01.70.0
Bimatoprost Formulation C7.411.125.951.93.70.00.0
Minoxidil 2% Solution1.816.137.541.13.60.00.0
Vehicle to Bimatoprost1.614.823.054.16.60.00.0

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Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
InterventionPercentage of participants (Number)
Greatly IncreasedModerately IncreasedSlightly IncreasedRemained the SameSlightly DecreasedModerately DecreasedGreatly Decreased
Bimatoprost Formulation A0.01.80.087.310.90.00.0
Bimatoprost Formulation B0.00.06.881.411.90.00.0
Bimatoprost Formulation C0.02.16.381.310.40.00.0
Minoxidil 2% Solution0.00.017.079.21.91.90.0
Vehicle to Bimatoprost0.01.66.688.53.30.00.0

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Change From Baseline in Target Area Hair Width (TAHW)

Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
Interventionmm/cm^2 (Mean)
BaselineChange from Baseline from Month 6
Bimatoprost Formulation A8.920.13
Bimatoprost Formulation B9.64-0.19
Bimatoprost Formulation C8.860.30
Minoxidil 2% Solution9.760.87
Vehicle to Bimatoprost10.130.07

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Change From Baseline in Target Area Hair Darkness (TAHD)

Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs). (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
InterventionIntensity units (Mean)
BaselineChange from Baseline at Month 6
Bimatoprost Formulation A95.632.94
Bimatoprost Formulation B100.124.22
Bimatoprost Formulation C92.762.11
Minoxidil 2% Solution93.072.12
Vehicle to Bimatoprost96.902.07

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Change From Baseline in Target Area Hair Count (TAHC)

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs). (NCT01325350)
Timeframe: Baseline, Month 6

,,,,
Interventionterminal hairs/cm^2 (Mean)
BaselineChange from Baseline at Month 6
Bimatoprost Formulation A153.1-0.4
Bimatoprost Formulation B161.1-3.5
Bimatoprost Formulation C145.24.3
Minoxidil 2% Solution156.313.6
Vehicle to Bimatoprost163.01.1

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Change From Baseline in Eyelash Thickness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement). (NCT01391273)
Timeframe: Baseline, Month 4

,
Interventionmm^2 (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%0.980.35
Bimatoprost Vehicle Solution1.01-0.03

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Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)

Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement). (NCT01391273)
Timeframe: Baseline, Month 4

,
Interventionmm (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%6.921.62
Bimatoprost Vehicle Solution7.00-0.04

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Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)

The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement. (NCT01391273)
Timeframe: Baseline, Month 4

InterventionPercentage of participants (Number)
Bimatoprost Solution 0.03%77.3
Bimatoprost Vehicle Solution17.6

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Change From Baseline in Eyelash Darkness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). (NCT01391273)
Timeframe: Baseline, Month 4

,
InterventionUnits on a scale (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%147.57-12.02
Bimatoprost Vehicle Solution145.271.38

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Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)

The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement. (NCT01391286)
Timeframe: Baseline, Month 4

InterventionPercentage of participants (Number)
Bimatoprost Solution 0.03%88.9
Bimatoprost Vehicle Solution27.8

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Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)

Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement). (NCT01391286)
Timeframe: Baseline, Month 4

,
Interventionmm (Median)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%5.702.70
Bimatoprost Vehicle Solution5.000.6

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Change From Baseline in Eyelash Thickness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement). (NCT01391286)
Timeframe: Baseline, Month 4

,
Interventionmm^2 (Median)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%0.600.80
Bimatoprost Vehicle Solution0.450.25

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Change From Baseline in Eyelash Darkness as Measured by DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). (NCT01391286)
Timeframe: Baseline, Month 4

,
InterventionUnits on a scale (Median)
BaselineChange from Baseline at Month 4
Bimatoprost Solution 0.03%140.15-19.40
Bimatoprost Vehicle Solution144.98-10.03

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Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score

The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement. (NCT01448525)
Timeframe: Baseline, Week 16

InterventionPercentage of participants (Number)
Bimatoprost Ophthalmic Solution 0.03%72.1
Bimatoprost Vehicle Solution19.0

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Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall

"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported." (NCT01448525)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Bimatoprost Ophthalmic Solution 0.03%67.4
Bimatoprost Vehicle Solution7.1

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Mean IOP at Each After Office Hour Evaluation Timepoint

IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. (NCT01464424)
Timeframe: Week 6: 4 pm, 6 pm, 8 pm

,
Interventionmillimeters mercury (mmHg) (Mean)
4 pm (20 hours post dose)6 pm (22 hours post dose)8 pm (24 hours post dose)
LUMIGAN17.0817.3217.26
TRAVATAN17.7417.5217.06

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Overall Mean Intraocular Pressure (IOP)

IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis. (NCT01464424)
Timeframe: Week 6

Interventionmillimeters mercury (mmHg) (Mean)
TRAVATAN17.45
LUMIGAN17.22

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Physician Reported Reasons for Early Discontinuation of Treatment

The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. (NCT01489670)
Timeframe: 12 Weeks

InterventionParticipants (Number)
Unacceptable ocular tolerabilityPatient decision to withdraw from studyInsufficient IOP controlPhysician decision to withdraw patient from studyPatient lost to follow upOther reasonMissing data
Lumigan® 0.01%2821188161

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Intraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline. (NCT01489670)
Timeframe: Baseline

Interventionmm Hg (Median)
Right Eye (n=334)Left Eye
Lumigan® 0.01%22.022.0

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Number of Patients Continuing Treatment After 12 Weeks

The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? (NCT01489670)
Timeframe: Week 12

InterventionParticipants (Number)
Lumigan® 0.01%302

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Intraocular Pressure (IOP) at Week 12

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement. (NCT01489670)
Timeframe: Week 12

Interventionmm Hg (Median)
Right Eye (n=334)Left Eye
Lumigan® 0.01%16.016.0

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Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale

Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported. (NCT01489670)
Timeframe: Week 12

InterventionParticipants (Number)
Very goodGoodModeratePoor
Lumigan® 0.01%157144716

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Physician Evaluation of Efficacy Using a 5-Point Scale

The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported. (NCT01489670)
Timeframe: Week 12

InterventionParticipants (Number)
IOP lower than targetTarget IOP reachedIOP decreased but target not reachedIOP increasedNo Change
Lumigan® 0.01%8718764615

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Physician Evaluation of Tolerability of Treatment

The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported. (NCT01489670)
Timeframe: Week 12

InterventionParticipants (Number)
Very goodGoodModeratePoor
Lumigan® 0.01%174141126

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Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement. (NCT01525173)
Timeframe: Baseline, Week 12

,
Interventionmm Hg (Mean)
BaselineChange from Baseline at Week 12
ALPHAGAN® P and LUMIGAN®22.3-4.7
LUMIGAN® Alone22.2-4.0

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Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline

IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. (NCT01547598)
Timeframe: Baseline, Week 12

Interventionpercentage of participants (Number)
LUMIGAN® RC26.2
DuoTrav®47.6

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Change From Baseline in Mean IOP at Week 6

IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement. (NCT01547598)
Timeframe: Baseline, Week 6

,
InterventionmmHg (Mean)
Baseline_ 8 AMChange from Baseline at Week 6 _8 AM (n=66,64)Baseline_12 NoonChange from Baseline at Week 6_12 Noon (n=66,64)Baseline_4 PMChange from Baseline at Week 6_4 PM (n=66,64)
DuoTrav®22.0-4.820.3-2.819.8-2.9
LUMIGAN® RC22.0-2.820.6-2.119.8-1.5

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Change From Baseline in Mean IOP at Week 12

IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement. (NCT01547598)
Timeframe: Baseline, Week 12

,
InterventionmmHg (Mean)
Baseline_8 AMChange from Baseline at Week 12 _8 AM (n=61,63)Baseline_12 NoonChange from Baseline at Week 12_12 Noon (n=61,63)Baseline_4 PMChange from Baseline at Week 12_4 PM (n=61,63)
DuoTrav®22.0-4.520.3-2.319.8-2.4
LUMIGAN® RC22.0-2.720.6-1.919.8-1.3

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Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg

IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. (NCT01547598)
Timeframe: Week 12

Interventionpercentage of participants (Number)
LUMIGAN® RC11.5
DuoTrav®17.5

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Mean Diurnal Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. (NCT01547598)
Timeframe: Week 12

InterventionmmHg (Mean)
LUMIGAN® RC18.6
DuoTrav®17.4

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Physician Reported Reasons for Treatment Discontinuation

The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. (NCT01568008)
Timeframe: 12 weeks

InterventionParticipants (Number)
Unacceptable ocular tolerabilityInsufficient IOP controlPatient lost to follow upPatient decision to withdraw from studyPhysician decision to withdraw patient from studyOther reason
All Participants462011866

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Number of Patients Continuing Treatment After 12 Weeks

The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? (NCT01568008)
Timeframe: 12 weeks

InterventionParticipants (Number)
All Participants755

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Intraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline. (NCT01568008)
Timeframe: Baseline

Interventionmm Hg (Mean)
Right Eye (n=885)Left Eye
All Participants22.0422.07

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Physician Assessment of Treatment Tolerability Using a 4-Point Scale

The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. (NCT01568008)
Timeframe: 12 weeks

InterventionParticipants (Number)
Very goodGoodModeratePoor
All Participants4893314924

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Intraocular Pressure (IOP) at Week 12

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement. (NCT01568008)
Timeframe: Week 12

Interventionmm Hg (Mean)
Right Eye (n=885)Left Eye
All Participants16.9417.02

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Patient Assessment of Treatment Tolerability Using a 4-Point Scale

Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. (NCT01568008)
Timeframe: 12 weeks

InterventionParticipants (Number)
Very goodGoodModeratePoor
All Participants4603176150

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Patient Assessment of Tolerability on a 4-Point Scale

Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01589510)
Timeframe: Week 14

InterventionPatients (Number)
Very GoodGoodModeratePoor
Lumigan® 0.01%201167169

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IOP at Week 14

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14. (NCT01589510)
Timeframe: Week 14

InterventionMillimeters of Mercury (Mean)
Right EyeLeft Eye (n=389)
Lumigan® 0.01%15.9216.05

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Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment

Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No. (NCT01589510)
Timeframe: 14 Weeks

InterventionPercentage of Patients (Number)
Lumigan® 0.01%7.9

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Intraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. (NCT01589510)
Timeframe: Baseline

InterventionMillimeters of Mercury (mmHg) (Mean)
Right EyeLeft Eye (n=389)
Lumigan® 0.01%21.2321.38

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Physician Evaluation of IOP Lowering in the Study Eye(s)

IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. (NCT01589510)
Timeframe: Week 14

InterventionEyes (Number)
IOP lower than targetTarget IOP reachedIOP decreased but target not reachedIOP increasedNo changeData Missing
Lumigan® 0.01%832337361328

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Percentage of Patients Who Continue Lumigan® 0.01% Treatment

Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No. (NCT01589510)
Timeframe: Week 14

InterventionPercentage of Patients (Number)
Lumigan® 0.01%86.2

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Physician Assessment of Tolerability on a 4-Point Scale

Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01589510)
Timeframe: Week 14

InterventionPatients (Number)
Very GoodGoodModeratePoor
Lumigan® 0.01%20917184

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Change From Baseline in Intraocular Pressure (IOP)

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). (NCT01594970)
Timeframe: Baseline, Week 6, Week 12

,,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 6 (N=251, 204, 233)Change from Baseline at Week 12 (N=220, 165, 191)
Bimatoprost 0.01% (Naive Monotherapy)18.6-4.7-4.3
Bimatoprost 0.01% (Switched Monotherapy)17.0-2.6-2.8
Bimatoprost 0.01% (With Adjunctive Therapy)19.3-3.2-3.4

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Overall Percent Change From Baseline in IOP

IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement). (NCT01594970)
Timeframe: Baseline, Week 6, Week 12

,,
InterventionPercent Change (Mean)
Change from Baseline at Week 6 (N=251, 204, 233)Change from Baseline at Week 12 (N=220, 165, 191)
Bimatoprost 0.01% (Naive Monotherapy)-22.09-20.22
Bimatoprost 0.01% (Switched Monotherapy)-12.90-12.81
Bimatoprost 0.01% (With Adjunctive Therapy)-14.37-14.25

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Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale

Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented. (NCT01594970)
Timeframe: Week 12

,,
InterventionParticipants (Number)
NoneTraceMildModerateSevere
Bimatoprost 0.01% (Naive Monotherapy)407173315
Bimatoprost 0.01% (Switched Monotherapy)495447115
Bimatoprost 0.01% (With Adjunctive Therapy)207065306

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Change From Baseline in Hyperemia Severity in the Study Eye

Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented. (NCT01594970)
Timeframe: Baseline, Week 12

,,
InterventionParticipants (Number)
ImprovedNo ChangeWorsened
Bimatoprost 0.01% (Naive Monotherapy)119128
Bimatoprost 0.01% (Switched Monotherapy)81499
Bimatoprost 0.01% (With Adjunctive Therapy)1515917

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Number of Applications of Latisse® Per Week

Number of applications of Latisse® per week as reported by the subjects. (NCT01623479)
Timeframe: Day 1

InterventionNumber of Applications (Mean)
Hypotrichosis of the Eyelashes6.69

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Percentage of Subjects Satisfied With Latisse®

Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. (NCT01623479)
Timeframe: Day 1

InterventionPercentage of Subjects (Number)
Hypotrichosis of the Eyelashes92.48

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Percentage of Subjects Satisfied Wtih Their Eyelashes

Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. (NCT01623479)
Timeframe: Day 1

InterventionPercentage of Subjects (Number)
Hypotrichosis of the Eyelashes79.81

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Patient Assessment of Tolerability Using a 4-Point Scale

Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01628588)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT755

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Change From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. (NCT01628588)
Timeframe: Baseline, 14 Weeks

InterventionMillimeters of Mercury (mmHg) (Median)
Baseline - Right Eye (N=830)Change from Baseline at 14 Wks-Rt Eye (N=830)Baseline - Left Eye (N=836)Change from Baseline at 14 Wks-Lft Eye (N=836)
POAG or OHT19.0-4.020.0-5.0

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Physician Assessment of Tolerability Using a 4-Point Scale

Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01628588)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT788

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Patients Who Will Continue Use of Lumigan® After 14 Weeks

Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. (NCT01628588)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT723

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Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks

Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. (NCT01628588)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT70

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Physician Assessment of Tolerability Using a 4-Point Scale

Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01628601)
Timeframe: 18 Weeks

InterventionParticipants (Number)
POAG or OHT340

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Physician Assessment of Adherence to GANfort®

"Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported." (NCT01628601)
Timeframe: 18 Weeks

InterventionParticipants (Number)
POAG or OHT112

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Change From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. (NCT01628601)
Timeframe: Baseline, 18 Weeks

InterventionMillimeters of Mercury (mmHg) (Median)
Baseline - Right Eye (N=345)Change from Baseline at 18 Wks-Rt Eye (N=345)Baseline - Left Eye (N=344)Change from Baseline at 18 Wks-Lft Eye (N=344)
POAG or OHT22.0-6.022.0-6.0

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Patients Continuing With GANfort® After 18 Weeks

Patients continuing with GANfort® after 18 weeks was assessed as Yes or No. (NCT01628601)
Timeframe: 18 Weeks

InterventionParticipants (Number)
POAG or OHT329

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Patient Assessment of Tolerability Using a 4-Point Scale

Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01628601)
Timeframe: 18 Weeks

InterventionParticipants (Number)
POAG or OHT319

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Physician Assessment of Tolerability Using a 4-Point Scale

Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01632423)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT9571

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Patients Who Will Continue Use of Lumigan® After 14 Weeks

Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. (NCT01632423)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT9121

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Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks

Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. (NCT01632423)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT642

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Patient Assessment of Tolerability Using a 4-Point Scale

Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. (NCT01632423)
Timeframe: 14 Weeks

InterventionParticipants (Number)
POAG or OHT9227

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Change From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. (NCT01632423)
Timeframe: Baseline, 14 Weeks

InterventionMillimeters of Mercury (mmHg) (Median)
Baseline - Right Eye (N=10062)Change from Baseline at 14 Wks-Rt Eye (N=10062)Baseline - Left Eye (N=10074)Change from Baseline at 14 Wks-Lft Eye (N=10074)
POAG or OHT20.0-4.020.0-4.0

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Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment

Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. (NCT01646151)
Timeframe: 12 Weeks

InterventionPercentage of Patients (Number)
Bimatoprost6.6

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Intraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. (NCT01646151)
Timeframe: Baseline

InterventionMillimeters of Mercury (mmHg) (Mean)
Right EyeLeft Eye (n=2091)
Bimatoprost20.5120.65

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IOP at Week 12

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. (NCT01646151)
Timeframe: Week 12

InterventionMillimeters of Mercury (mmHg) (Mean)
Right EyeLeft Eye (n=2091)
Bimatoprost15.7815.87

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Patient Assessment of Tolerability on a 4-Point Scale

Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01646151)
Timeframe: Week 12

InterventionPatients (Number)
Very GoodGoodModeratePoor
Bimatoprost112710708070

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Physician Evaluation of IOP Lowering in the Study Eye(s)

IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. (NCT01646151)
Timeframe: Week 12

InterventionEyes (Number)
IOP lower than targetTarget IOP reachedIOP decreased but target not reachedIOP increasedNo changeData Missing
Bimatoprost622117346785119205

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Physician Assessment of Tolerability on a 4-Point Scale

Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01646151)
Timeframe: Week 12

InterventionPatients (Number)
Very GoodGoodModeratePoor
Bimatoprost121210597424

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Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops

Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. (NCT01646151)
Timeframe: Week 12

InterventionPercentage of Patients (Number)
Bimatoprost85.8

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Percentage of Subjects Who Reached Target IOP at Each Visit

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Week 6, Month 3, Month 6

,
Interventionpercentage of participants (Number)
Week 6, n=46,46Month 3, n=46,44Month 6, n=46,43
LUMIGAN56.570.567.4
TRAVATAN69.671.773.9

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Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Month 6

,
InterventionmmHg (Mean)
Baseline (Day 0)Change from Baseline at Month 6, n=46,43
LUMIGAN24.59-7.35
TRAVATAN24.66-7.61

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Mean Change From Baseline in IOP at Week 6 and Month 3

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Week 6, Month 3

,
InterventionmmHg (Mean)
Change from Baseline at Week 6, n=46,46Change from Baseline at Month 3, n=46,44
LUMIGAN-7.02-7.82
TRAVATAN-7.50-7.96

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Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit

Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Week 6, Month 3, Month 6

,
Interventionparticipants (Number)
Baseline, Grade 0Baseline, Grade 1Baseline, Grade 2-1 Grade Change from Baseline at Week 60 Grade Change from Baseline at Week 6+1 Grade Change from Baseline at Week 6+2 Grade Change from Baseline at Week 6-1 Grade Change from Baseline at Month 30 Grade Change from Baseline at Month 3+1 Grade Change from Baseline at Month 3+2 Grade Change from Baseline at Month 3-1 Grade Change from Baseline at Month 60 Grade Change from Baseline at Month 6+1 Grade Change from Baseline at Month 6+2 Grade Change from Baseline at Month 6
LUMIGAN31171123202115262115252
TRAVATAN4091220231213256020233

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Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6

Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Month 3, Month 6

,
Interventionparticipants (Number)
Baseline, Grade 0Baseline, Grade 1Baseline, Grade 2-1 Grade Change from Baseline at Month 30 Grade Change from Baseline at Month 3+1 Grade Change from Baseline at Month 3-1 Grade Change from Baseline at Month 60 Grade Change from Baseline at Month 6+1 Grade Change from Baseline at Month 6+2 Grade Change from Baseline at Month 6
LUMIGAN39914337725101
TRAVATAN41817336428131

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Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6

Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Month 3, Month 6

,
Interventionparticipants (Number)
Baseline, Grade 0Baseline, Grade 1Baseline, Grade 2Month 3, -1 Grade Change from BaselineMonth 3, 0 Grade Change from BaselineMonth 3, +1 Grade Change from BaselineMonth 3, +2 Grade Change from BaselineMonth 6, -1 Grade Change from BaselineMonth 6, 0 Grade Change from BaselineMonth 6, +1 Grade Change from BaselineMonth 6, +2 Grade Change from Baseline
LUMIGAN39916335072691
TRAVATAN446063631431110

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Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6

TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. (NCT01664039)
Timeframe: Baseline (Day 0), Month 3, Month 6

,
Interventionseconds (Mean)
Baseline (Day 0)Change from Baseline at Month 3, n=46,44Change from Baseline at Month 6, n=46,43
LUMIGAN11.7-1.8-2.2
TRAVATAN10.7-1.6-2.2

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Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6

"The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health." (NCT01664039)
Timeframe: Baseline (Day 0), Month 3, Month 6

,
Interventionunits on a scale (Mean)
Baseline (Day 0)Change from Baseline at Month 3, n=44,43Change from Baseline at Month 6, n=44,42
LUMIGAN10.60.01.7
TRAVATAN14.6-0.30.4

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Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement) (NCT01698554)
Timeframe: Baseline, Month 4

,,,
Interventionmm (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Formulation A Solution6.091.61
Bimatoprost Solution 0.03 %5.971.62
Vehicle of Bimatoprost Formulation A Solution5.900.08
Vehicle of Bimatoprost Solution 0.03 %6.030.05

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Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement). (NCT01698554)
Timeframe: Baseline, Month 4

,,,
Interventionintensity units (Mean)
BaselineChange from Baseline at Month 4
Bimatoprost Formulation A Solution145.33-23.98
Bimatoprost Solution 0.03 %147.39-24.78
Vehicle of Bimatoprost Formulation A Solution147.44-2.78
Vehicle of Bimatoprost Solution 0.03 %145.790.17

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Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement. (NCT01698554)
Timeframe: Baseline, Month 4

Interventionpercentage of participants (Number)
Bimatoprost Formulation A Solution82.4
Bimatoprost Solution 0.03 %83.4
Vehicle of Bimatoprost Formulation A Solution24.0
Vehicle of Bimatoprost Solution 0.03 %20.3

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Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement). (NCT01698554)
Timeframe: Baseline Month 4

,,,
Interventionmm^2 (Mean)
BaselineChange from Baseline At Month 4
Bimatoprost Formulation A Solution0.850.58
Bimatoprost Solution 0.03 %0.820.64
Vehicle of Bimatoprost Formulation A Solution0.760.02
Vehicle of Bimatoprost Solution 0.03 %0.810.03

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Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported." (NCT01698554)
Timeframe: Month 4

Interventionpercentage of participants (Number)
Bimatoprost Formulation A Solution71.2
Bimatoprost Solution 0.03 %65.0
Vehicle of Bimatoprost Formulation A Solution28.0
Vehicle of Bimatoprost Solution 0.03 %20.3

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Change From Baseline in Eyebrow Darkness as Measured Using DMSIA

Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement). (NCT01765764)
Timeframe: Baseline, Month 7

,,
Interventionintensity units (Mean)
BaselineChange from Baseline at Month 7
Bimatoprost Solution BID53.90-4.53
Bimatoprost Solution QD53.59-3.76
Vehicle to Bimatoprost Solution BID52.870.11

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Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)

Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement). (NCT01765764)
Timeframe: Baseline, Month 7

,,
Interventionmm^2 (Mean)
BaselineChange from Baseline at Month 7
Bimatoprost Solution BID101.0834.51
Bimatoprost Solution QD97.8030.96
Vehicle to Bimatoprost Solution BID98.176.42

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Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale

The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported. (NCT01765764)
Timeframe: Baseline, Month 7

Interventionpercentage of participants (Number)
Bimatoprost Solution BID83.9
Bimatoprost Solution QD77.1
Vehicle to Bimatoprost Solution BID43.0

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Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6

"ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported." (NCT01765764)
Timeframe: Month 7

Interventionpercentage of participants (Number)
Bimatoprost Solution BID70.3
Bimatoprost Solution QD52.5
Vehicle to Bimatoprost Solution BID36.4

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Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). (NCT01814761)
Timeframe: Baseline, Week 12

,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineWeek 12 (N=34, 240)
Pts With POAG or OH (Previously Treatment Naive)18.0-3.6
Pts With POAG or OH (Switched Monotherapy)17.8-2.6

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Overall Percent Change From Baseline in IOP

IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening). (NCT01814761)
Timeframe: Baseline, Week 12

InterventionPercentage Change (Mean)
Pts With POAG or OH (Previously Treatment Naive)-19.25
Pts With POAG or OH (Switched Monotherapy)-13.26

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Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale

Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented. (NCT01814761)
Timeframe: 12 Weeks

,
InterventionPatients (Number)
NoneTraceMildModerateSevereMissing
Pts With POAG or OH (Previously Treatment Naive)71012508
Pts With POAG or OH (Switched Monotherapy)365084591130

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Percentage of Patients Who Discontinue Due to an Adverse Event

An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. (NCT01814761)
Timeframe: 12 Weeks

InterventionPercentage of Patients (Number)
Pts With POAG or OH (Previously Treatment Naive)14.3
Pts With POAG or OH (Switched Monotherapy)5.6

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Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye

Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye. (NCT01830140)
Timeframe: Baseline, 6 Weeks

InterventionPercentage of Patients (Number)
Bimatoprost 0.01%34.3
Bimatoprost 0.03%39.1

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Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, Week 6, Week 12

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 6Change from Baseline at Week 12
Bimatoprost 0.01%20.3-3.5-3.7

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Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, Week 6, Week 12

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 6Change from Baseline at Week 12
Bimatoprost 0.01%20.8-3.8-3.7

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Percentage of Patients Discontinuing Due to Ocular Adverse Events

Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. (NCT01833741)
Timeframe: 12 Weeks

InterventionPercentage of Patients (Number)
Bimatoprost 0.01%3.9

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Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, 12 Weeks

InterventionPercent Change (Mean)
Bimatoprost 0.01%-16.1

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Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, 12 Weeks

InterventionPercent Change (Mean)
Bimatoprost 0.01%-16.1

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Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients

IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, 12 Weeks

InterventionPercent Change (Mean)
Bimatoprost 0.01%-30.9

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Percentage of Treatment-Naive Patients With Ocular Hyperemia

Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry. (NCT01833741)
Timeframe: Week 12

InterventionPercentage of Patients (Number)
0 (none)+0.5 (trace)+1 (mild)+2 (moderate)+3 (severe)
Bimatoprost 0.01%32.239.821.35.90.9

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Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia

Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. (NCT01833741)
Timeframe: Week 12

InterventionPercentage of Patients (Number)
0 (none)+0.5 (trace)+1 (mild)+2 (moderate)+3 (severe)
Bimatoprost 0.01%35.541.017.36.00.3

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Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia

Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. (NCT01833741)
Timeframe: Week 12

InterventionPercentage of Patients (Number)
0 (none)+0.5 (trace)+1 (mild)+2 (moderate)+3 (severe)
Bimatoprost 0.01%28.436.924.19.21.4

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Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT01833741)
Timeframe: Baseline, Week 6, Week 12

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 6Change from Baseline at Week 12
Bimatoprost 0.01%23.5-7.4-7.7

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Patient Assessment of Tolerability on a 4-Point Scale

Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01853085)
Timeframe: 12 Weeks

InterventionPatients (Number)
Very GoodGoodModeratePoor
Patients With POAG or OHT9136707374

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Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment

Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. (NCT01853085)
Timeframe: 12 Weeks

InterventionPatients (Number)
Patients With POAG or OHT139

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Number of Patients Who Continue Treatment

Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. (NCT01853085)
Timeframe: 12 Weeks

InterventionPatients (Number)
Patients With POAG or OHT1501

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IOP in the Study Eye at Week 12

IOP is a measurement of the fluid pressure inside the study eye. (NCT01853085)
Timeframe: Week 12

InterventionmmHg (Mean)
Patients With POAG or OHT16.38

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Intraocular Pressure (IOP) in the Study Eye at Baseline

IOP is a measurement of the fluid pressure inside the study eye. (NCT01853085)
Timeframe: Baseline

InterventionMillimeters of Mercury (mmHg) (Mean)
Patients With POAG or OHT21.15

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Physician Assessment of Tolerability on a 4-Point Scale

Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. (NCT01853085)
Timeframe: 12 Weeks

InterventionPatients (Number)
Very GoodGoodModeratePoor
Patients With POAG or OHT9826487838

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Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale

IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented. (NCT01853085)
Timeframe: Baseline, 12 Weeks

InterventionPatients (Number)
Better than ExpectedAs ExpectedWorse than Expected
Patients With POAG or OHT649916151

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Change From Baseline in Average Eye Mean Diurnal IOP

IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). (NCT01863953)
Timeframe: Baseline, Day 14, Day 28

,,
InterventionmmHg (Mean)
BaselineChange from Baseline at Day 14Change from Baseline at Day 28
Bimatoprost Ophthalmic Solution 0.01% and Vehicle24.38-6.79-6.98
Brimonidine Tartrate Ophthalmic Solution 0.2%24.29-4.67-4.22
Fixed-Combination Bimatoprost/Brimonidine24.54-7.63-7.25

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Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). (NCT01863953)
Timeframe: Baseline, Day 42

,,
InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Day 42 (N=38, 36, 37)
Bimatoprost Ophthalmic Solution 0.01% and Vehicle24.38-6.63
Brimonidine Tartrate Ophthalmic Solution 0.2%24.29-3.92
Fixed-Combination Bimatoprost/Brimonidine24.54-6.79

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Average Eye Mean Diurnal IOP

IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. (NCT01863953)
Timeframe: Day 14, Day 28, Day 42

,,
InterventionmmHg (Mean)
Day 14Day 28Day 42 (N=38, 36, 37)
Bimatoprost Ophthalmic Solution 0.01% and Vehicle17.5917.4017.76
Brimonidine Tartrate Ophthalmic Solution 0.2%19.6120.0620.34
Fixed-Combination Bimatoprost/Brimonidine16.9117.2917.75

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Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. (NCT01881126)
Timeframe: Week 12 at 8 AM, 12 PM, and 4 PM

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Week 12 at 8 AMWeek 12 at 12 PMWeek 12 at 4 PM
Bimatoprost 0.01% and Hypromellose 0.3%16.416.016.5
Travatan 0.004% and Timolol 0.5%15.115.014.5

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Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01904721)
Timeframe: Month 6

,,
InterventionPercentage of Participants (Number)
Greatly increasedModerately increasedSlightly increasedRemained the sameSlightly decreasedModerately decreasedGreatly decreased
Stage 2: Bimatoprost Solution 1 Twice Daily6.514.533.930.612.91.60.0
Stage 2: Bimatoprost Solution 2 Twice Daily4.825.433.323.812.70.00.0
Stage 2: Bimatoprost Vehicle Twice Daily0.06.720.035.030.06.71.7

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Change From Baseline in Target Area Hair Darkness (TAHD)

Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs). (NCT01904721)
Timeframe: Baseline, Month 6

,,
InterventionIntensity Units (Mean)
BaselineChange from Baseline at Month 6
Stage 2: Bimatoprost Solution 1 Twice Daily115.76-6.31
Stage 2: Bimatoprost Solution 2 Twice Daily113.77-1.63
Stage 2: Bimatoprost Vehicle Twice Daily115.22-1.62

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Change From Baseline in Target Area Hair Count (TAHC)

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs). (NCT01904721)
Timeframe: Baseline, Month 6

,,
Interventionterminal hairs/cm2 (Mean)
BaselineChange from Baseline at Month 6
Stage 2: Bimatoprost Solution 1 Twice Daily140.412.7
Stage 2: Bimatoprost Solution 2 Twice Daily131.39.3
Stage 2: Bimatoprost Vehicle Twice Daily129.05.8

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Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01904721)
Timeframe: Month 6

,,
InterventionPercentage of Participants (Number)
Greatly increasedModerately increasedSlightly increasedRemained the sameSlightly decreasedModerately decreasedGreatly decreased
Stage 2: Bimatoprost Solution 1 Twice Daily11.317.725.841.93.20.00.0
Stage 2: Bimatoprost Solution 2 Twice Daily4.822.233.336.53.20.00.0
Stage 2: Bimatoprost Vehicle Twice Daily0.03.323.360.013.30.00.0

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Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented." (NCT01904721)
Timeframe: Month 6

,,
InterventionPercentage of Participants (Number)
Greatly increasedModerately increasedSlightly increasedRemained the sameSlightly decreasedModerately decreasedGreatly decreased
Stage 2: Bimatoprost Solution 1 Twice Daily3.315.035.043.33.30.00.0
Stage 2: Bimatoprost Solution 2 Twice Daily1.69.740.345.23.20.00.0
Stage 2: Bimatoprost Vehicle Twice Daily0.00.015.572.410.31.70.0

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Change From Baseline in Target Area Hair Width (TAHW)

Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). (NCT01904721)
Timeframe: Baseline, Month 6

,,
Interventionmm/cm2 (Mean)
BaselineChange from Baseline at Month 6
Stage 2: Bimatoprost Solution 1 Twice Daily7.820.92
Stage 2: Bimatoprost Solution 2 Twice Daily7.320.67
Stage 2: Bimatoprost Vehicle Twice Daily7.300.05

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Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 0) to Week 12

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T=2 hour)Baseline (T=8 hour)Change from Baseline to Week 12 (T=0 hour)Change from Baseline to Week 12 (T=2 hour)Change from Baseline to Week 12 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-5.26-4.26-3.99
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-6.31-5.60-5.19

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Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 0) to Week 2

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T=2 hour)Baseline (T=8 hour)Change from Baseline to Week 2 (T=0 hour)Change from Baseline to Week 2 (T=2 hour)Change from Baseline to Week 2 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-6.40-5.20-4.21
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-6.30-5.59-4.96

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Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 0) to Week 6

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T=2 hour)Baseline (T=8 hour)Change from Baseline to Week 6 (T=0 hour)Change from Baseline to Week 6 (T=2 hour)Change from Baseline to Week 6 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-5.47-4.70-3.78
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-6.41-5.40-4.42

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Change From Baseline in IOP at Month 4

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 1) to Month 4

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T=2 hour)Baseline (T=8 hour)Change from Baseline to Month 4 (T=0 hour)Change from Baseline to Month 4 (T=2 hour)Change from Baseline to Month 4 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-5.14-4.37-3.84
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-6.29-5.26-5.11

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Change From Baseline in IOP at Month 6

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 0) to Month 6

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T=2 hour)Baseline (T=8 hour)Change from Baseline to Month 6 (T=0 hour)Change from Baseline to Month 6 (T=2 hour)Change from Baseline to Month 6 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-4.58-3.87-3.25
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-5.97-5.20-4.24

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Change From Baseline in IOP at Month 5

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. (NCT01915940)
Timeframe: Baseline (Day 0) to Month 5

,
Interventionmm Hg (Mean)
Baseline (T=0 hour)Baseline (T= 2 hour)Baseline (T=8 hour)Change from Baseline to Month 5 (T=0 hour)Change from Baseline to Month 5 (T=2 hour)Change from Baseline to Month 5 (T=8 hour)
13 mg Bimatoprost Ocular Insert24.9923.6522.95-4.28-3.87-3.21
Timolol 0.5% + Placebo Ocular Insert25.3423.7523.16-6.35-5.45-4.47

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Change From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days. (NCT01976624)
Timeframe: Baseline, Week 4

InterventionmmHg (Mean)
Right Eye: Baseline (n=608)Right Eye: Change from Baseline (n=608)Left Eye: Baseline (n=616)Left Eye: Change from Baseline (n=616)
Ganfort®18.23-3.2818.23-3.50

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Number of Participants With Adverse Events and Adverse Drug Reactions

An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. (NCT01976624)
Timeframe: Up to 51 months

Interventionparticipants (Number)
Adverse EventsAdverse Drug Reactions
Ganfort®146134

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Percentage of Patients Prescribed by the Physician to Continue Treatment

The percentage of participants who continued treatment with Ganfort® UD after Week 12. (NCT01999348)
Timeframe: Final Visit (Week 8 to 12)

Interventionpercentage of participants (Number)
Patients With POAG or OHT89.14

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Percentage of Patients Who Discontinued Treatment

The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit (NCT01999348)
Timeframe: 12 Weeks

Interventionpercentage of participants (Number)
Patients With POAG or OHT6.47

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Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement). (NCT01999348)
Timeframe: Baseline, Final Visit (Week 8 to 12)

InterventionmmHg (Mean)
BaselineFinal Visit
Patients With POAG or OHT22.1816.11

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Patient Assessment of Tolerability on a 4-Point Scale

The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. (NCT01999348)
Timeframe: Final Visit (Week 8 to 12)

Interventionparticipants (Number)
Very goodGoodModeratePoorMissing
Patients With POAG or OHT788461455047

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Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale

The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported. (NCT01999348)
Timeframe: Baseline, Final Visit (Week 8 to 12)

Interventionparticipants (Number)
Better than expectedAs expectedWorse than expectedMissing data
Patients With POAG or OHT4977299867

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Physician Assessment of Tolerability on a 4-Point Scale

The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. (NCT01999348)
Timeframe: Final Visit (Week 8 to 12)

Interventionparticipants (Number)
Very goodGoodModeratePoorMissing
Patients With POAG or OHT809474402840

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Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). (NCT02020512)
Timeframe: Baseline, Week 5

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Week 5
0.03% Bimatoprost22.2-6.7

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Percentage of Patients With an Adverse Event of Conjunctival Hyperemia

Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. (NCT02061683)
Timeframe: 3 Months

InterventionPercentage of Patients (Number)
Bimatoprost 0.03%76.0

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Intraocular Pressure (IOP) in the Study Eye

IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy). (NCT02061683)
Timeframe: Month 3

InterventionMillimeters of Mercury (mmHg) (Mean)
Group A (N=89)Group B (N=33)Group C (N=67)Group D (N=18)Group E (N=33)
Bimatoprost 0.03%16.516.715.716.117.2

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Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. (NCT02097719)
Timeframe: Week 12 at 8 AM, 12 PM, and 4 PM

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Week 12 at 8 AM (N=46, 50)Week 12 at 12 PM (N=46, 50)Week 12 at 4 PM (N=47, 50)
Bimatoprost 0.01% and Hypromellose 0.3%16.716.216.0
Travoprost 0.004% and Timolol 0.5%15.415.615.4

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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. (NCT02143843)
Timeframe: 13 months

Interventionpercentage of participants (Number)
Ocular, MildOcular, ModerateOcular, SevereNon-ocular, MildNon-ocular, ModerateNon-ocular, Severe
13 mg Bimatoprost Ocular Insert53.314.71.312.018.71.3

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Change From Baseline in Mean Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940]. (NCT02143843)
Timeframe: Baseline (Day 1) to Month 13

Interventionmm Hg (Median)
13 mg Bimatoprost Ocular Insert-4

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Percent Change in Target Area Total Hair Count

The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study. (NCT02170662)
Timeframe: Baseline to week 17; and week 17 to week 34

,
Interventionpercentage change in total hair count (Mean)
Part 1: Baseline to week 17Part 2: week 17 to week 34
Bimatoprost Then Placebo27.4-5.8
Placebo Then Bimatoprost-2.64.9

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Percent Change in the Target Area Terminal Hair Count

Terminal hairs are those which grow beyond a cm and contribute to overall hair density. (NCT02170662)
Timeframe: Baseline to week 17; and week 17 to week 34

,
Interventionpercent change of terminal hair count (Mean)
Part 1: Baseline to week 17Part 2: week 17 to week 34
Bimatoprost Then Placebo12.1-8.3
Placebo Then Bimatoprost-2.1-5.1

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Percent Change in the Target Area Vellus Hair Count

Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness (NCT02170662)
Timeframe: Baseline to week 17; and week 17 to week 34

,
InterventionPercent change of vellus hair count (Mean)
Part 1: Baseline to week 17;Part 2: week 17 to week 34
Bimatoprost Then Placebo78.12.9
Placebo Then Bimatoprost-2.65.1

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Change From Baseline in Aging Appearance Using a 7-item Questionnaire

Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants45.0728.47

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Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)

The investigator assessed the severity of the participant's GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants2.6-1.6

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Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS

The investigator assessed the severity of the participant's CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
Left_BaselineLeft_Change from Baseline at Month 4Right_BaselineRight_Change from Baseline at Month 4
All Participants2.5-1.02.5-1.0

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Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)

The investigator assessed the participant's eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants1.81.5

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Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire

Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants62.7819.89

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Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire

Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants41.2231.70

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Change From Baseline in Social Confidence Using an 8-item Questionnaire

Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants62.7018.24

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Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity

The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants2.6-1.0

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Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity

The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants2.1-0.9

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Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS

The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants3.1-1.7

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Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity

The investigator assessed the participant's perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst]. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants2.0-1.1

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Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area

Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Month 4
All Participants21.1-12.6

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Participant's Self- Perception of Age (SPA)

Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance). (NCT02176356)
Timeframe: Baseline, Month 4

Interventionyears (Mean)
BaselineMonth 4
All Participants0.2-4.6

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Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)

Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement. (NCT02176356)
Timeframe: Baseline, Month 4

Interventionyears (Mean)
BaselineChange from Baseline at Month 4 (n=92)
All Participants0.1-4.6

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IOP in the Study Eye at Week 2 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 2 (Hour 0)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg16.82
Bimatoprost SR 10 μg17.02
Timolol 0.5%: Comparator17.83

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IOP in the Study Eye at Week 2 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 2 (Hour 2)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg16.48
Bimatoprost SR 10 μg16.42
Timolol 0.5%: Comparator17.33

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IOP in the Study Eye at Week 6 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 6 (Hour 0)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg17.08
Bimatoprost SR 10 μg16.88
Timolol 0.5%: Comparator17.71

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IOP in the Study Eye at Week 6 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 6 (Hour 2)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg16.62
Bimatoprost SR 10 μg16.51
Timolol 0.5%: Comparator17.16

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Change From Baseline in IOP in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT02247804)
Timeframe: Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

,,
Interventionmm Hg (Least Squares Mean)
Change from Baseline at Hour 0, Week 2Change from Baseline at Hour 2, Week 2Change from Baseline at Hour 0, Week 6Change from Baseline at Hour 2, Week 6
Bimatoprost SR 10 μg-6.97-7.57-7.11-7.48
Bimatoprost SR 15 μg-7.17-7.52-6.91-7.37
Timolol 0.5%: Comparator-6.17-6.67-6.29-6.83

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Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT02247804)
Timeframe: Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)

,,
Interventionmillimeters of mercury (mm Hg) (Least Squares Mean)
Change from Baseline at Hour 0, Week 12Change from Baseline at Hour 2, Week 12
Bimatoprost SR 10 μg-6.38-6.69
Bimatoprost SR 15 μg-6.46-7.18
Timolol 0.5%: Comparator-6.05-6.48

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IOP in the Study Eye at Week 12 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 12 (Hour 0)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg17.53
Bimatoprost SR 10 μg17.61
Timolol 0.5%: Comparator17.94

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IOP in the Study Eye at Week 12 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02247804)
Timeframe: Week 12 (Hour 2)

Interventionmm Hg (Least Squares Mean)
Bimatoprost SR 15 μg16.81
Bimatoprost SR 10 μg17.30
Timolol 0.5%: Comparator17.51

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IOP in the Study Eye at Week 6 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 6 (Hour 2)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg16.13
Bimatoprost SR 10 μg16.53
Timolol 0.5%: Comparator17.18

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Change From Baseline in IOP in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT02250651)
Timeframe: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

,,
InterventionmmHg (Least Squares Mean)
Change from Baseline at Week 2, Hour 0Change from Baseline at Week 2, Hour 2Change from Baseline at Week 6, Hour 0Change from Baseline at Week 6, Hour 2
Bimatoprost SR 10 μg-6.94-7.38-6.93-7.33
Bimatoprost SR 15 μg-7.12-7.77-6.81-7.74
Timolol 0.5%: Comparator-6.36-6.67-6.35-6.69

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IOP in the Study Eye at Week 12 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 12 (Hour 0)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg17.39
Bimatoprost SR 10 μg17.68
Timolol 0.5%: Comparator17.75

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IOP in the Study Eye at Week 12 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 12 (Hour 2)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg16.70
Bimatoprost SR 10 μg17.15
Timolol 0.5%: Comparator17.50

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IOP in the Study Eye at Week 2 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 2 (Hour 0)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg16.74
Bimatoprost SR 10 μg16.92
Timolol 0.5%: Comparator17.50

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IOP in the Study Eye at Week 2 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 2 (Hour 2)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg16.09
Bimatoprost SR 10 μg16.48
Timolol 0.5%: Comparator17.19

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IOP in the Study Eye at Week 6 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. (NCT02250651)
Timeframe: Week 6 (Hour 0)

InterventionmmHg (Least Squares Mean)
Bimatoprost SR 15 μg17.05
Bimatoprost SR 10 μg16.93
Timolol 0.5%: Comparator17.51

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Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT02250651)
Timeframe: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)

,,
Interventionmillimeters of mercury (mmHg) (Least Squares Mean)
Change from Baseline at Week 12, Hour 0Change from Baseline at Week 12, Hour 2
Bimatoprost SR 10 μg-6.18-6.72
Bimatoprost SR 15 μg-6.47-7.16
Timolol 0.5%: Comparator-6.11-6.36

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Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 8

,,
Interventionpercentage of participants (Number)
Right Eye, 10+ Letter ImprovementRight Eye, 5+ Letter ImprovementRight Eye, No ChangeRight Eye, 5- Letter WorseningRight Eye, 10- Letter WorseningLeft Eye, 10+ Letter ImprovementLeft Eye, 5+ Letter ImprovementLeft Eye, No ChangeLeft Eye, 5- Letter WorseningLeft Eye, 10- Letter Worsening
13 mg Bimatoprost Ocular Insert (Period A/B)2.85.677.813.905.619.466.75.62.8
2.2 mg Bimatoprost Ocular Insert (Period A/B)07.769.217.95.1020.566.77.75.1
Placebo Ocular Insert + Timolol 0.5% (Period A/B)2.618.465.813.202.610.568.415.82.6

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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 12

,,
Interventionpercentage of participants (Number)
Ocular, MildOcular, ModerateOcular, SevereNon-ocular, MildNon-Ocular, ModerateNon-ocular, Severe
13 mg Bimatoprost Ocular Insert (Period A/B)26.84.909.87.30
2.2 mg Bimatoprost Ocular Insert (Period A/B)17.55.005.02.52.5
Placebo Ocular Insert + Timolol 0.5% (Period A/B)12.52.505.015.00

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Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12

Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported. (NCT02358369)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Right Eye, NoneLeft Eye, NoneRight Eye, MildLeft Eye, MildRight Eye, ModerateLeft Eye, Moderate
13 mg Bimatoprost Ocular Insert (Period A/B)50.047.244.450.05.62.8
2.2 mg Bimatoprost Ocular Insert (Period A/B)71.171.126.326.32.62.6
Placebo Ocular Insert + Timolol 0.5% (Period A/B)63.262.234.235.12.62.7

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Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12

The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 12

Interventionpercentage of participants (Number)
Placebo Ocular Insert + Timolol 0.5% (Period A/B)0
2.2 mg Bimatoprost Ocular Insert (Period A/B)0
13 mg Bimatoprost Ocular Insert (Period A/B)0

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Change From Baseline in Automated Visual Field at Week 12

Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 12

,,
Interventiondecibels (dB) (Mean)
BaselineChange from Baseline to Week 12
13 mg Bimatoprost Ocular Insert (Period A/B)-2.700.39
2.2 mg Bimatoprost Ocular Insert (Period A/B)-1.450.02
Placebo Ocular Insert + Timolol 0.5% (Period A/B)-2.58-0.18

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Change From Baseline in Intraocular Pressure (IOP) at Week 8

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 8

,,
Interventionmm Hg (Mean)
Change from Baseline to Week 8 (T=0 hour)Change from Baseline to Week 8 (T=2 hour)Change from Baseline to Week 8 (T=8 hour)
13 mg Bimatoprost Ocular Insert (Period A/B)-4.56-3.98-3.22
2.2 mg Bimatoprost Ocular Insert (Period A/B)-3.68-3.31-3.23
Placebo Ocular Insert + Timolol 0.5% (Period A/B)-4.68-3.62-3.21

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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. (NCT02358369)
Timeframe: Week 12 to Week 24

Interventionpercentage of participants (Number)
Ocular, MildOcular, ModerateOcular, SevereNon-ocular, MildNon-ocular, ModerateNon-ocular, Severe
13 mg Bimatoprost Ocular Insert (Period C)23.95.305.34.40.9

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Change From Baseline in IOP at Week 12

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 12

,,
Interventionmm Hg (Mean)
Change from Baseline to Week 12 (T=0 hour)Change from Baseline to Week 12 (T=2 hour)Change from Baseline to Week 12 (T=8 hour)
13 mg Bimatoprost Ocular Insert (Period A/B)-4.08-3.40-2.69
2.2 mg Bimatoprost Ocular Insert (Period A/B)-3.64-3.67-3.20
Placebo Ocular Insert + Timolol 0.5% (Period A/B)-3.37-2.74-2.34

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Change From Baseline in IOP at Week 2

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 2

,,
Interventionmm Hg (Mean)
Change from Baseline to Week 2 (T=0 hour)Change from Baseline to Week 2 (T=2 hour)Change from Baseline to Week 2 (T=8 hour)
13 mg Bimatoprost Ocular Insert (Period A/B)-5.95-5.34-4.52
2.2 mg Bimatoprost Ocular Insert (Period A/B)-4.56-4.14-3.76
Placebo Ocular Insert + Timolol 0.5% (Period A/B)-6.84-5.71-4.81

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Change From Baseline in IOP at Week 6

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 6

,,
Interventionmm Hg (Mean)
Change from Baseline to Week 6 (T=0 hour)Change from Baseline to Week 6 (T=2 hour)Change from Baseline to Week 6 (T=8 hour)
13 mg Bimatoprost Ocular Insert (Period A/B)-5.30-4.42-3.77
2.2 mg Bimatoprost Ocular Insert (Period A/B)-4.87-4.40-3.73
Placebo Ocular Insert + Timolol 0.5% (Period A/B)-6.42-4.97-4.40

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Change From Baseline in IOP in Period C

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. (NCT02358369)
Timeframe: Baseline (Day 0) to Weeks 14, 18 and 24

Interventionmm Hg (Mean)
Change from Baseline to Week 14 (T=0 hour)Change from Baseline to Week 14 (T=2 hour)Change from Baseline to Week 14 (T=8 hour)Change from Baseline to Week 18 (T=0 hour)Change from Baseline to Week 18 (T=2 hour)Change from Baseline to Week 18 (T=8 hour)Change from Baseline to Week 24 (T=0 hour)Change from Baseline to Week 24 (T=2 hour)Change from Baseline to Week 24 (T=8 hour)
13 mg Bimatoprost Ocular Insert (Period C)-5.72-4.64-4.13-5.62-4.33-4.17-4.85-3.99-2.99

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Dilated Fundus Exam: Cup-to-Disc-Ratio

The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma. (NCT02358369)
Timeframe: Week 12

,,
Interventionratio (Mean)
Right Eye, Week 12Left Eye, Week 12
13 mg Bimatoprost Ocular Insert (Period A/B)0.470.48
2.2 mg Bimatoprost Ocular Insert (Period A/B)0.550.56
Placebo Ocular Insert + Timolol 0.5% (Period A/B)0.530.54

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Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. (NCT02358369)
Timeframe: Baseline (Day 0) to Week 12

,,
Interventionpercentage of participants (Number)
Right Eye, 10+ Letter ImprovementRight Eye, 5+ Letter ImprovementRight Eye, No ChangeRight Eye, 5- Letter WorseningRight Eye, 10- Letter WorseningLeft Eye, 10+ Letter ImprovementLeft Eye, 5+ Letter ImprovementLeft Eye, No ChangeLeft Eye, 5- Letter WorseningLeft Eye, 10- Letter Worsening
13 mg Bimatoprost Ocular Insert (Period A/B)2.811.161.122.22.85.619.461.113.90
2.2 mg Bimatoprost Ocular Insert (Period A/B)05.357.928.97.9013.268.415.82.6
Placebo Ocular Insert + Timolol 0.5% (Period A/B)07.973.713.25.307.971.118.42.6

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Mean Diurnal IOP at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Week 6

InterventionmmHg (Mean)
SIMBRINZA + PGA17.2
Vehicle + PGA20.9

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Mean Percentage Change From Baseline at 09:00 at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

Interventionpercent change (Mean)
SIMBRINZA + PGA-21.0
Vehicle + PGA-10.9

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Mean Percentage Change From Baseline in Diurnal IOP at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

Interventionpercent change (Mean)
SIMBRINZA + PGA-24.7
Vehicle + PGA-9.5

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Mean Percentage Change From Baseline in IOP at 11:00 at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

Interventionpercent change (Mean)
SIMBRINZA + PGA-31.3
Vehicle + PGA-10.8

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Mean Change From Baseline in IOP at 09:00 at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

,
InterventionmmHg (Mean)
BaselineChange from baseline
SIMBRINZA + PGA23.4-4.9
Vehicle + PGA23.4-2.5

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Mean Change From Baseline in IOP at 11:00 at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

,
InterventionmmHg (Mean)
BaselineChange from baseline
SIMBRINZA + PGA22.4-7.0
Vehicle + PGA22.6-2.4

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Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6

IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. (NCT02419508)
Timeframe: Baseline, Week 6

InterventionmmHg (Mean)
SIMBRINZA + PGA-5.6
Vehicle + PGA-2.1

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Number of Days Until the First Nail Chipped

Average number of days post-treatment until the first nail chipped (NCT02448043)
Timeframe: Baseline to 30 days

InterventionDays (Mean)
Bimatoprost 0.01% Drops8.38
Placebo6.26

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Intraocular Pressure at 30 Days of Treatment

IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM (NCT02448043)
Timeframe: Between 7:30 AM and 10:00 AM at 30 days post treatment

,
Interventionmm Hg (Mean)
Both eyesRight eyeLeft eye
Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo13.9114.013.82
Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo16.4216.3816.46

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Change From Baseline in Nail Length of Hands

Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA) (NCT02448043)
Timeframe: Baseline, 30 days

,
Interventionmm (Mean)
Total Nail Growth (power = 1.0)Individual Nail Growth
Bimatoprost 0.01% Drops13.491.34
Placebo15.101.51

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Nail Brittleness at 30 Days of Treatment

"Scale Title: Nail Brittleness (1-4)~Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness)." (NCT02448043)
Timeframe: Baseline, 30 days

InterventionScore on a scale (Mean)
Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo2.25
Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo2.43

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Change From Baseline in Nail Length of Digits

Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA) (NCT02448043)
Timeframe: Baseline, 30 Days

,
Interventionmm (Mean)
ThumbForefingerMiddle FingerRing FingerPinky Finger
Bimatoprost 0.01% Drops1.581.260.901.331.63
Placebo1.481.021.401.761.62

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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. (NCT02537015)
Timeframe: Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Interventionpercentage of participants (Number)
Ocular, MildOcular, ModerateOcular, SevereNon-Ocular, MildNon-Ocular, ModerateNon-Ocular, Severe
13 mg Bimatoprost Ocular Insert25.911.106.28.64.9

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Change From Baseline in IOP at Week 12

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. (NCT02636946)
Timeframe: Baseline (prior to treatment) to Week 12

InterventionmmHg (Least Squares Mean)
Selective Laser Trabeculoplasty-6.28
Bim SR 15 μg-6.81

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Change From Baseline in Intraocular Pressure (IOP) at Week 24

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. (NCT02636946)
Timeframe: Baseline (prior to treatment) to Week 24

InterventionmmHg (Least Squares Mean)
Selective Laser Trabeculoplasty-6.34
Bim SR 15 μg-6.59

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Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3. (NCT02636946)
Timeframe: Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20

,
Interventionpercentage of participants (Number)
Cycle 1 Day 2Cycle 1 Week 4Cycle 1 Week 8Cycle 1 Week 12Cycle 1 Week 15Cycle 1 Week 20Cycle 1 Week 24Cycle 1 Week 28Cycle 1 Week 31Cycle 1 Week 36Cycle 1 Week 40Cycle 1 Week 44Cycle 1 Week 47Cycle 1 Week 52Cycle 2 Day 2Cycle 2 Week 4Cycle 2 Week 8Cycle 2 Week 12Cycle 2 Week 15Cycle 2 Week 20Cycle 2 Week 24Cycle 2 Week 28Cycle 2 Week 31Cycle 2 Week 36Cycle 3 Day 2Cycle 3 Week 4Cycle 3 Week 8Cycle 3 Week 15Cycle 3 Week 20
Bim SR 15 μg92.778.080.075.264.240.045.545.540.072.754.545.554.581.889.575.271.065.364.364.871.374.174.467.090.971.059.443.339.4
Selective Laser Trabeculoplasty60.670.272.967.967.250.081.863.6100.072.754.581.872.781.870.268.868.572.069.476.964.476.576.779.175.874.275.070.069.7

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Change From Baseline in IOP at Weeks 8, 15, and 20

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. (NCT02636946)
Timeframe: Baseline (prior to treatment) to Weeks 8, 15 and 20

,
InterventionmmHg (Mean)
Change from Baseline at Week 8Change from Baseline at Week 15Change from Baseline at Week 20
Bim SR 15 μg-7.09-5.36-4.29
Selective Laser Trabeculoplasty-6.65-6.14-5.06

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Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator

Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. (NCT02636946)
Timeframe: First treatment to end of study (up to 525 days)

Interventiondays (Median)
Selective Laser Trabeculoplasty410
Bim SR 15 μg446

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Intraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. (NCT02636946)
Timeframe: Baseline (prior to treatment)

Interventionmillimeters of mercury (mmHg) (Mean)
Selective Laser Trabeculoplasty24.45
Bim SR 15 μg24.38

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Change From Baseline in IOP at Week 4

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses. (NCT02636946)
Timeframe: Baseline (prior to treatment) to Week 4

InterventionmmHg (Least Squares Mean)
Selective Laser Trabeculoplasty-6.28
Bim SR 15 μg-6.98

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Intraocular Pressure (IOP) on Day 8

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 8

,,
Interventionmm Hg (Mean)
Day 8 (T=0 hour)Day 8 (T=4 hour)Day 8 (T=8 hour)
Bimatoprost Ocular Insert19.1518.9617.84
Fixed Combination (FC) Ocular Insert17.8317.5117.05
Timolol Ocular Insert19.5919.8819.66

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IOP on Day 70

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 70

,,
Interventionmm Hg (Mean)
Day 70 (T=0 hour)Day 70 (T=4 hour)Day 70 (T=8 hour)
Bimatoprost Ocular Insert17.7818.7118.61
Fixed Combination (FC) Ocular Insert17.6018.0917.14
Timolol Ocular Insert17.7918.4818.78

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IOP on Day 49

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 49

,,
Interventionmm Hg (Mean)
Day 49 (T=0 hour)Day 49 (T=4 hour)Day 49 (T=8 hour)
Bimatoprost Ocular Insert18.8819.3518.48
Fixed Combination (FC) Ocular Insert18.5517.7717.23
Timolol Ocular Insert18.6319.6719.13

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IOP on Day 28

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 28

,,
Interventionmm Hg (Mean)
Day 28 (T=0 hour)Day 28 (T=4 hour)Day 28 (T=8 hour)
Bimatoprost Ocular Insert18.4419.5918.77
Fixed Combination (FC) Ocular Insert18.0318.5417.26
Timolol Ocular Insert19.7520.0919.20

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Number of Participants With Ocular and Non-Ocular Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events. (NCT02742649)
Timeframe: From Randomization (Day 0) to Day 70

,,
InterventionParticipants (Count of Participants)
OcularNon-Ocular
Bimatoprost Ocular Insert1410
Fixed Combination (FC) Ocular Insert1311
Timolol Ocular Insert105

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IOP During Open Label Period

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 98, Day 112

,,
Interventionmm Hg (Mean)
Day 98 (T=0 hour)Day 98 (T=4 hour)Day 98 (T=8 hour)Day 112 (T=0 hour)Day 112 (T=4 hour)Day 112 (T=8 hour)
Bimatoprost Ocular Insert22.6922.3822.8820.6518.5218.43
Fixed Combination (FC) Ocular Insert22.6121.6720.7419.2117.6217.51
Timolol Ocular Insert23.2422.9922.6319.7118.7518.19

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IOP on Day 16

IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint. (NCT02742649)
Timeframe: Day 16

,,
Interventionmm Hg (Mean)
Day 16 (T=0 hour)Day 16 (T=4 hour)Day 16 (T=8 hour)
Bimatoprost Ocular Insert18.0818.6418.54
Fixed Combination (FC) Ocular Insert18.2917.9517.21
Timolol Ocular Insert20.8121.0819.43

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Change in Patient Satisfaction

"Entry and exit surveys were completed about self perception of the periocular area. The satisfaction was measured based on 2 short surveys. Entry survey had 1 question how do you rate your satisfaction with your appearance? - the scale was 0-5, with 0 being Not at all to 5 being extremely. The exit survey posed two questions, (1) how do you rate satisfaction with your appearance? with the same 0-5 scale, as well as (2) Do you notice an improvement in your eyelid droop (dermatochalasis)? with a scale as follows: Worse (-1), No Change (0), 25% better (1), 50% better (2), 75% better (3), or 100% better (4). The change in satisfaction was measured by the summation of scores from both surveys and the average was calculated." (NCT02830776)
Timeframe: Weeks 0, 12

Interventionunits on a scale (Mean)
Treatment Group.214

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Graded Change in Dermatochalasis

Patients were followed for 12 weeks total, with visits every 4 weeks for a total of 4 visits. Photodocumentation was performed at each visit. At completion of the study period, each patient's photographs at weeks 0 and 12, were graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive). The change of dermatochalasis (week 12 score subtracted from week 0 score) was the primary outcome measure. A greater change (based on a higher score) in dermatochalasis indicated better response to the treatment. (NCT02830776)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Treatment Group.2679

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Intra-Ocular Pressure

Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye (NCT03825380)
Timeframe: Week 12

InterventionmmHg (Mean)
T4032-9.67
Lumigan®-9.50

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Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. (NCT04285580)
Timeframe: 8 weeks

,
InterventionMillimeters of Mercury (mmHg) (Mean)
Diurnal/Wake Period Hour 08:00Diurnal/Wake Period Hour 10:00Diurnal/Wake Period Hour 12:00Diurnal/Wake Period Hour 14:00Diurnal/Wake Period Hour 16:00Diurnal/Wake Period Hour 18:00Diurnal/Wake Period Hour 20:00Diurnal/Wake Period Hour 22:00Nocturnal/Sleep Period Hour 00:00Nocturnal/Sleep Period Hour 02:00Nocturnal/Sleep Period Hour 04:00Nocturnal/Sleep Period Hour 06:00
Bimatoprost SR 10 μg-3.7-2.5-2.9-1.8-3.3-1.9-2.6-2.3-1.7-2.4-2.1-2.2
LUMIGAN 0.01%-4.0-3.2-5.0-4.4-4.2-4.2-5.0-2.1-1.8-3.2-3.2-5.0

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Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

The number of patients who experienced one or more TEAEs (NCT04285580)
Timeframe: Up to 12 Months

InterventionParticipants (Count of Participants)
Bimatoprost SR 10 μg12
LUMIGAN 0.01%4

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Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP. (NCT04285580)
Timeframe: 8 Weeks

InterventionMillimeters of Mercury (mmHg) (Mean)
Bimatoprost SR 10 μg-1.6
LUMIGAN 0.01%0.7

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