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brimonidine tartrate

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Description

Brimonidine Tartrate: A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID11236066
CHEMBL ID2062257
SCHEMBL ID34649
MeSH IDM0065049

Synonyms (25)

Synonym
AC-3599
agn-190342-lf
brimonidine tartrate
5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)-6-quinoxalinamine tartrate
brimonidine tartarate
AKOS015895446
CHEMBL2062257
ocu300
ocu-300
SCHEMBL34649
59803-99-5
brimonidine d-tartarate
uk 14,304 tartrate
5-bromo-6-(2-imidazolin-2-ylamino)quinoxaline tartrate
mfcd07773072
HMS3652B06
brimonidine tartrateuk 14,304 tartrate
HMS3677O18
5-bromo-6-(2-imidazolidinylideneamino) quinoxaline l-tartrate
zincarsenite
BCP28473
HMS3413O18
5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)quinoxalin-6-amine;2,3-dihydroxybutanedioic acid
A927815
SY065942

Research Excerpts

Toxicity

Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.

ExcerptReferenceRelevance
" Various parameters were evaluated, including glaucoma medications (visit 1), IOP (visit 1-visit 3), and adverse events."( The effectiveness and safety of brimonidine as mono-, combination, or replacement therapy for patients with primary open-angle glaucoma or ocular hypertension: a post hoc analysis of an open-label community trial. Glaucoma Trial Study Group.
Abrams, C; Gornbein, J; Lee, DA, 2000
)
0.31
" Both drug regimens appeared to be safe and were well tolerated."( Ongoing clinical assessment of the safety profile and efficacy of brimonidine compared with timolol: year-three results. Brimonidine Study Group II.
David, R; Melamed, S, 2000
)
0.31
" Study subjects within medication treatment groups were classified as to their use or nonuse of concurrent systemic beta-blockers, and mean intraocular pressure (IOP) reduction, adverse events, heart rate, and blood pressure were compared."( Effects of systemic beta-blocker therapy on the efficacy and safety of topical brimonidine and timolol. Brimonidine Study Groups 1 and 2.
Schuman, JS, 2000
)
0.31
" Adverse events and mean changes in heart rate and blood pressure from baseline were the primary safety variables."( Effects of systemic beta-blocker therapy on the efficacy and safety of topical brimonidine and timolol. Brimonidine Study Groups 1 and 2.
Schuman, JS, 2000
)
0.31
" Patients who were treated for less than three months, who failed therapy due to ineffectiveness of the medicine or an adverse event also were included."( Comparison of the efficacy and safety of latanoprost 0.005% compared to brimonidine 0.2% or dorzolamide 2% when added to a topical beta-adrenergic blocker in patients with primary open-angle glaucoma or ocular hypertension.
Chopra, H; Day, DG; Holmes, KT; Kolker, AE; Konstas, AG; Lee, WH; Rieser, JC; Sharpe, ED; Stewart, WC, 2000
)
0.31
" Safety and tolerability parameters included adverse events and quality-of-life measures (e."( Effectiveness and safety of brimonidine as adjunctive therapy for patients with elevated intraocular pressure in a large, open-label community trial.
Gornbein, JA; Lee, DA, 2001
)
0.31
" Safety was measured by monitoring adverse events."( A 3-month comparison of efficacy and safety of brimonidine-purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension.
Batoosingh, A; Felix, C; Mundorf, T; Whitcup, S; Williams, R, 2003
)
0.32
" There were no statistically significant differences between the two groups in the overall incidence of adverse events."( A 3-month comparison of efficacy and safety of brimonidine-purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension.
Batoosingh, A; Felix, C; Mundorf, T; Whitcup, S; Williams, R, 2003
)
0.32
" Demographic data, reduction of IOP, safety and adverse events were obtained and analyzed."( The efficacy and safety of brimonidine 0.2% compared with timolol 0.5% in glaucoma: a randomized clinical trial on Taiwanese patients.
Chen, MJ; Chou, JC; Hsu, WM; Liu, JH, 2003
)
0.32
"0% patients in timolol group reported mild adverse events."( The efficacy and safety of brimonidine 0.2% compared with timolol 0.5% in glaucoma: a randomized clinical trial on Taiwanese patients.
Chen, MJ; Chou, JC; Hsu, WM; Liu, JH, 2003
)
0.32
" It has a safe systemic profile with minimum effect on the heart."( The efficacy and safety of brimonidine 0.2% compared with timolol 0.5% in glaucoma: a randomized clinical trial on Taiwanese patients.
Chen, MJ; Chou, JC; Hsu, WM; Liu, JH, 2003
)
0.32
" Being a newer drug, the whole spectrum of its adverse effects is not known."( Dermatological side effects of brimonidine: a report of three cases.
Ratan, J; Sodhi, PK; Verma, L, 2003
)
0.32
" There have been occasional reports of systemic adverse effects in children including apparent central nervous system depression."( Ocular and systemic side effects of brimonidine 0.2% eye drops (Alphagan) in children.
Bowman, RJ; Cope, J; Nischal, KK, 2004
)
0.32
"2% because of adverse side effects (two because of local irritation/allergy, two because of tiredness, and two because of fainting attacks)."( Ocular and systemic side effects of brimonidine 0.2% eye drops (Alphagan) in children.
Bowman, RJ; Cope, J; Nischal, KK, 2004
)
0.32
" In this study, 18% of children had systemic adverse effects sufficient to necessitate stopping the drug."( Ocular and systemic side effects of brimonidine 0.2% eye drops (Alphagan) in children.
Bowman, RJ; Cope, J; Nischal, KK, 2004
)
0.32
"Topical application of ocular drugs may cause serious adverse ocular or systemic side effects."( Systemic side effects of ophthalmic drops.
Levy, Y; Zadok, D,
)
0.13
" Both agents were well tolerated with adverse events consistent with the package inserts."( Comparison of the safety and efficacy of dorzolamide 2% and brimonidine 0.2% in patients with glaucoma or ocular hypertension.
Fechtner, RD; Henry, C; Hughes, B; Lee, DA; Terry, S; Whitson, JT, 2004
)
0.32
" Physicians should be aware of its side effect profile because of its general use in the paediatric population."( Is brimonidine ophthalmic a safe therapy for infants?
Daubert, GP, 2006
)
0.33
" Patient discontinuations resulting from adverse events were similar for both groups and most of these were a result of signs or symptoms of ocular allergic reaction."( The safety and intraocular pressure-lowering efficacy of brimonidine tartrate 0.15% preserved with polyquaternium-1.
Andrew, RM; Bergamini, MV; Bosworth, CF; Dickerson, JE; James, JE; Landry, TA; Moster, MR; Ochsner, KI; Silver, LH; Sullivan, EK; Wells, DT; Whitson, JT, 2006
)
0.33
" A review of the literature reveals that when used in young infants brimonidine eye drops can potentially have toxic effects on the central nervous system (e."( [Depression of respiration via toxic effects on the central nervous system following use of topical brimonidine in an infant with congenital glaucoma].
Heimann, K; Hoernchen, H; Merz, U; Peschgens, T; Wenzl, T, 2007
)
0.34
" Ocular burning was noted with dorzolamide more than any other adverse event with either drug."( Efficacy and safety of brimonidine and dorzolamide for intraocular pressure lowering in glaucoma and ocular hypertension.
Craven, ER; Katz, LJ; Simmons, ST, 2007
)
0.34
"We review available evidence regarding the efficacy and side effect profile of brimonidine as well as its role in glaucoma management."( Efficacy, safety, and current applications of brimonidine.
Batiste, C; Fudemberg, SJ; Katz, LJ, 2008
)
0.35
"Treatment-related adverse events (AEs) and discontinuations due to AEs."( Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: a meta-analysis of two phase 3 studies.
Batoosingh, AL; Cantor, LB; Hollander, DA; Liu, CC, 2009
)
0.35
" A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n=58, 26."( Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%.
Goode, SM; McMenemy, MG; Nguyen, QH; Realini, T; Whitson, JT, 2013
)
0.39
" Evaluations included severity of erythema based on Clinician's Erythema Assessment and Patient's Self-Assessment, as well as adverse events."( Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies.
Fowler, J; Jackson, M; Jarratt, M; Jones, T; Leoni, M; Meadows, K; Moore, A; Rudisill, D; Steinhoff, M, 2013
)
0.39
"5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase."( Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study.
Kempers, S; Leoni, M; Liu, H; Moore, A; Murakawa, G; Swinyer, L; Tauscher, A; Weiss, J, 2014
)
0.4
" Among them, 1 failed to meet the inclusion/exclusion criteria, 10 revoked their consent to participate in the study, 3 had adverse reactions, and 1 had a drug adherence rate of less than 70%."( Comparison of the intraocular pressure-lowering effect and safety of brimonidine/timolol fixed combination and 0.5% timolol in normal-tension glaucoma patients.
Kim, CY; Kim, HK; Kim, JM; Kim, TW; Park, KH, 2016
)
0.43
" The safety profile and risk of systemic toxic effects when brimonidine is used topically for hemostasis is unknown."( Association of Central Nervous System Depression With Topical Brimonidine When Used for Hemostasis: A Serious Adverse Event.
Schleichert, R; Shagalov, DR; Taylor, D; Weiss, E; Weiss, J, 2017
)
0.46
"33%, gel can result in systemic central nervous system toxic effects when used as a hemostatic agent."( Association of Central Nervous System Depression With Topical Brimonidine When Used for Hemostasis: A Serious Adverse Event.
Schleichert, R; Shagalov, DR; Taylor, D; Weiss, E; Weiss, J, 2017
)
0.46
" This study investigated the effects of brimonidine on auditory HCs that were also exposed to gentamicin, which is toxic to HCs."( Brimonidine Protects Auditory Hair Cells from in vitro-Induced Toxicity of Gentamicin.
Bodmer, D; Cortada, M; Levano, S, 2017
)
0.46
" Safety assessments included adverse events (AEs), rebound redness on treatment discontinuation, comprehensive ophthalmic exams, and vital signs."( Evaluation of Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution, 0.025% for Treatment of Ocular Redness.
DeCory, HH; Gomes, PJ; Sanfilippo, CM; Torkildsen, GL, 2018
)
0.48
" The intraocular pressure (IOP), mean deviation value, and adverse drug reactions were evaluated."( The Efficacy and Safety of the Fixed Combination of Brinzolamide 1% and Brimonidine 0.2% in Normal Tension Glaucoma: An 18-Month Retrospective Study.
Jin, SW; Lee, SM, 2018
)
0.48
" There were no serious adverse drug reactions."( The Efficacy and Safety of the Fixed Combination of Brinzolamide 1% and Brimonidine 0.2% in Normal Tension Glaucoma: An 18-Month Retrospective Study.
Jin, SW; Lee, SM, 2018
)
0.48
"BBFC provides a significant IOP reduction and is a safe antiglaucoma medication for NTG patients."( The Efficacy and Safety of the Fixed Combination of Brinzolamide 1% and Brimonidine 0.2% in Normal Tension Glaucoma: An 18-Month Retrospective Study.
Jin, SW; Lee, SM, 2018
)
0.48
"Uveitis due to brimonidine is a rare adverse effect, but it must be known."( Hypertensive acute granulomatous anterior uveitis as a side effect of topical brimonidine.
Arciniegas-Perasso, CA; Clemente-Tomás, R; Duch-Samper, AM; García-Ibor, F; Hervás-Hernandis, JM; Ruiz-Del Río, N, 2018
)
0.48
" Treatment-related adverse events were usually injection procedure-related."( PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.
Augustin, AJ; Boyer, DS; Freeman, WR; Guo, Q; Kerr, KJ; Kuppermann, BD; López, FJ; Patel, SS; Schneider, S, 2021
)
0.62
" Case series and prospective double-blind treatment studies also give evidence for the occurrence of several central nervous system adverse reactions."( A review of neuropsychiatric adverse events from topical ophthalmic brimonidine.
Cimolai, N, 2020
)
0.56
" Ocular treatment-emergent adverse events occurred in 42."( Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma.
Kim, JM; Lee, JW; Maglambayan, J; Park, KH; Park, SW; Simonyi, S, 2021
)
0.62
"Brimonidine had a similar side effect profile to the fix combination."( Comparing the effects and safety of dorzolamide hydrochloride + timolol maleate versus brimonidine after neodymium-doped yttrium aluminium garnet laser capsulotomy posterior capsule opacification.
Çakmak, K; Erbil, H; Korkmaz, Ş; Mesci, C, 2022
)
0.72
"BBFC had satisfactory IOP-lowering effects without serious adverse reactions in patients who switched medications."( Intraocular pressure-lowering effects and safety of brimonidine/brinzolamide fixed combination after switching from other medications.
Inoue, K; Ishida, K; Kunimatsu-Sanuki, S; Tomita, G, 2022
)
0.72
" Secondary outcome measurements included visual acuity, IOP, drug tolerance, tear-film break-up time, hemodynamic changes including blood pressure and heart rates, and ocular adverse events."( Comparisons of efficacy and safety between preserved and preservative-free brimonidine tartrate in glaucoma and ocular hypertension: a parallel-grouped, randomized trial.
Kim, KE; Kim, Y; Lee, CK; Rho, S; Shin, J, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Drug elimination from aqueous humor was rapid initially with a half-life of 1 hr in rabbits, followed by a slower decline phase in pigmented rabbits."( Comparative ocular pharmacokinetics of brimonidine after a single dose application to the eyes of albino and pigmented rabbits.
Acheampong, AA; Shackleton, M; Tang-Liu, DD, 1995
)
0.29
" Statistical analysis was performed to compare the pharmacokinetic parameters between the control and disease animal models."( Ocular pharmacokinetics of intravitreally administered brimonidine and dexamethasone in animal models with and without blood-retinal barrier breakdown.
Burke, J; Durairaj, C; Lin, T; Liu, Y; Shen, J, 2014
)
0.4
" Therefore, extrapolation of ocular pharmacokinetic data obtained in normal animals to disease models for the purpose of pharmacokinetic/pharmacodynamic data analysis should be performed with caution."( Ocular pharmacokinetics of intravitreally administered brimonidine and dexamethasone in animal models with and without blood-retinal barrier breakdown.
Burke, J; Durairaj, C; Lin, T; Liu, Y; Shen, J, 2014
)
0.4
"A pharmacokinetic study was conducted to compare intraindividual systemic exposures after dermal application of BT gel (0·07%, 0·18% and 0·5%) under maximal use conditions in patients with moderate-to-severe facial erythema associated with rosacea, and administration of BT ophthalmic solution 0·2%."( Comparative pharmacokinetics and bioavailability of brimonidine following ocular and dermal administration of brimonidine tartrate ophthalmic solution and gel in patients with moderate-to-severe facial erythema associated with rosacea.
Benkali, K; Bouer, R; Fernando, A; Graeber, M; Leoni, M; Rony, F; Wagner, N, 2014
)
0.4
"Patients who received BT ophthalmic solution 0·2% three times a day for 1 day had a mean Cmax of 54 ± 28 pg mL(-1) and a mean 0-24-h area under the curve (AUC0-24 h ) of 568 ± 277 pg h mL(-1) ."( Comparative pharmacokinetics and bioavailability of brimonidine following ocular and dermal administration of brimonidine tartrate ophthalmic solution and gel in patients with moderate-to-severe facial erythema associated with rosacea.
Benkali, K; Bouer, R; Fernando, A; Graeber, M; Leoni, M; Rony, F; Wagner, N, 2014
)
0.4

Compound-Compound Interactions

ExcerptReferenceRelevance
"To examine the relevance of concentration of benzalkonium chloride (BAK) on the cornea, we investigated the effects of latanoprost containing BAK alone and in combination with other antiglaucoma drug classes on corneal epithelium in vitro in a cultured rabbit corneal cell line (SIRC) and in vivo, using a corneal resistance device (CRD)."( In vitro and in vivo corneal effects of latanoprost combined with brimonidine, timolol, dorzolamide, or brinzolamide.
Fukuda, M; Sasaki, H; Shibata, N; Shibata, S; Shibata, T; Sugiyama, K; Takeda, N, 2016
)
0.43
"The purpose of this study is to evaluate the outcome of a series of patients with erythematotelangiectatic rosacea (ETR) affected by persistent erythema and varying degree of telangiectasias being treated with brimonidine alone or combined with a vascular laser based on the type of vascular components preliminarily evaluated by clinical and instrumental observation."( Treatment of erythemato-telangiectatic rosacea with brimonidine alone or combined with vascular laser based on preliminary instrumental evaluation of the vascular component.
Bhatt, K; Dall'Oglio, F; Lacarrubba, F; Luppino, I; Micali, G; Verzì, AE, 2018
)
0.48

Bioavailability

ExcerptReferenceRelevance
" Taken together, the high alpha 2-adrenoceptor selectivity, ocular hypotensive efficacy, retinal bioavailability and neuroprotective properties make brimonidine an important addition to the field of antiglaucoma agents."( Preclinical evaluation of brimonidine.
Burke, J; Schwartz, M, 1996
)
0.29
" Posttranscriptional regulation of eNOS protein may explain differences in NO bioavailability in juvenile pigs."( Effect of puberty on coronary arteries from female pigs.
Bracamonte, MP; Chatrath, R; Jayachandran, M; LaBreche, P; Miller, VM; Ronningen, KL; Severson, SR, 2003
)
0.32
"The monoamine theory of depression proposes decreased bioavailability of monoamines, such as norepinephrine (NE), as the underlying cause of depression."( An antidepressant mechanism of desipramine is to decrease tumor necrosis factor-alpha production culminating in increases in noradrenergic neurotransmission.
Ignatowski, TA; Reynolds, JL; Spengler, RN; Sud, R, 2005
)
0.33
" The pH difference between these 2 formulations seemed to exert no effect on brimonidine bioavailability or the tolerability of the solution."( Absorption of brimonidine 0.1% and 0.15% ophthalmic solutions in the aqueous humor of cataract patients.
Cantor, LB; Catoira-Boyle, Y; WuDunn, D; Yung, CW,
)
0.13
"Various efforts have been made to improve the bioavailability and to prolong the residence time of eye drops."( Chitosan nanoparticles for controlled delivery of brimonidine tartrate to the ocular membrane.
Shinde, UA; Singh, KH, 2011
)
0.37
"The bioavailability of therapeutic agents from eye drops is usually limited due to corneal barrier functions and effective eye protective mechanisms."( Biodegradable ocular inserts for sustained delivery of brimonidine tartarate: preparation and in vitro/in vivo evaluation.
Aburahma, MH; Mahmoud, AA, 2011
)
0.37
"The poor bioavailability and therapeutic response exhibited by conventional eye drops due to rapid precorneal elimination of the drug may be overcome by the use of an in situ gelling systems that are instilled as drops into the eye and undergo a sol-to-gel transition in the cul-de-sac which improves patient compliance as the dosage regimen is one drop of the dosage form twice a day."( Sustained ocular delivery of brimonidine tartrate using ion activated in situ gelling system.
Geethalakshmi, A; Jha, SK; Karki, R; Nikunj, B; Venkatesh, DP, 2012
)
0.38
"To assess the relative bioavailability of topical BT gel in comparison with the ophthalmic BT solution."( Comparative pharmacokinetics and bioavailability of brimonidine following ocular and dermal administration of brimonidine tartrate ophthalmic solution and gel in patients with moderate-to-severe facial erythema associated with rosacea.
Benkali, K; Bouer, R; Fernando, A; Graeber, M; Leoni, M; Rony, F; Wagner, N, 2014
)
0.4
"Topical drug administration to the eye is limited by low drug bioavailability due to its rapid clearance from the preocular surface."( Mucoadhesive microparticles with a nanostructured surface for enhanced bioavailability of glaucoma drug.
Choi, SY; Choy, YB; Chung, YJ; Jung, YE; Kim, MH; Kim, MJ; Kim, YK; Lee, SH; Lee, WS; Park, CG; Park, KH; Park, M, 2015
)
0.42
"Conventional eye drops quickly move away from the surface of the eye; as a result, ocular bioavailability is very limited."( Thermosensitive hexanoyl glycol chitosan-based ocular delivery system for glaucoma therapy.
Cho, IS; Cho, MO; Choy, YB; Huh, BK; Huh, KM; Kang, SW; Khatun, Z; Li, Z; Park, CG, 2016
)
0.43
"Short residence time, poor bioavailability and poor permeability are the major problems for conventional eye drops treatment."( Formulation and ex vivo-in vivo evaluation of pH-triggered brimonidine tartrate in situ gel for the glaucoma treatment using application of 3
Barse, RK; Kokare, CR; Sharma, JP; Sharma, PK; Tagalpallewar, AA, 2018
)
0.48
" However, the eye drops have limited effectiveness as a result of low drug bioavailability due to their rapid clearance from the preocular space."( Amino-Functionalized Mesoporous Silica Particles for Ocular Delivery of Brimonidine.
Choy, YB; Ha, A; Huh, BK; Kim, SN; Kim, YK; Ko, SA; Lee, SH; Park, CG; Park, KH; Park, YH, 2018
)
0.48
" It enhances the ocular bioavailability by reducing the drug protein binding, increasing the corneal resident time, enhancing the drug permeability and providing a sustained drug release."( Impact of Ocular Compatible Lipoids and Castor Oil in Fabrication of Brimonidine Tartrate Nanoemulsions by 3
Newton, MJ, 2018
)
0.48
" This is direct evidence for better bioavailability of nanobrimonidine after topical administration."( Effect of Ultra-Small Chitosan Nanoparticles Doped with Brimonidine on the Ultra-Structure of the Trabecular Meshwork of Glaucoma Patients.
Barwal, I; Dada, T; Kumar, R; Yadav, SC, 2019
)
0.51
"2% w/v brimonidine tartrate eye drop solution, which showed poor ocular bioavailability of 1-3%."( In vitro and in vivo evaluation of brimonidine loaded silica nanoparticles-laden silicone contact lenses to manage glaucoma.
Li, H; Xu, Y, 2022
)
0.72

Dosage Studied

Bimonidine tartrate (BT) is a common glaucoma medication. Up to 97% of patients not taking it as prescribed. A single dosage of BT requires dosing every 8-12 h.

ExcerptRelevanceReference
" We therefore compared the dose-response curves of three alpha-2 adrenoceptor agonists, clonidine, UK 14,304 and 2,6-DMC."( Opposite rank order of potency for alpha-2 adrenoceptor agonists on water and solute excretion in the rat: two sites and/or receptors?
Blandford, DE; Li, P; Penner, SB; Smyth, DD, 1992
)
0.28
" Pretreatment with the alpha 2 antagonist rauwolscine caused a 1 to 2 log unit right shift in the dose-response curve of UK in the CNM."( Pharmacological evidence for heterogeneity of ocular alpha 2 adrenoceptors.
Crosson, CE; DeVries, GW; Heath, AR; Potter, DE, 1992
)
0.28
" The second approach was a detailed comparison between alpha 2-receptor occupancy by [3H] UK 14304 and the cyclic AMP inhibitory dose-response curve to this agonist in cells incubated also under conditions avoiding cyclic AMP breakdown."( Evidence against the "spare" receptor nature of alpha 2-adrenoceptors in hamster white fat cells.
Dieudonne, MN; Giudicelli, Y; Pecquery, R, 1990
)
0.28
" However, the dose-response curves to phentolamine and the alpha-2 adrenoceptor agonist UK 14,304 on stimulus-induced overflow from the kidney were not significantly different after NE treatment."( Effects of chronic norepinephrine administration on sympathetic neurotransmission in the isolated perfused rat kidney.
Eikenburg, DC, 1990
)
0.28
" Dose-response curves to noradrenaline were unaffected by prazosin (1 microM)."( Alpha 2-adrenoceptor antisecretory responses in the rat jejunum.
Dettmar, PW; Downing, OA; Roach, AG; Urquhart, CJ; Williams, RJ; Wilson, KA, 1990
)
0.28
"Preincubation of HT29 cells with an alpha-2 adrenergic agonist resulted in a parallel rightward shift in the subsequent dose-response curve to 5-bromo-6-[2-imidazoline-2-yl-amino] quinoxaline (an alpha-2 adrenergic agonist) in inhibiting vasoactive intestinal peptide-stimulated cyclic AMP production."( Desensitization of the alpha-2 adrenergic receptor in HT29 and opossum kidney cell lines.
Bylund, DB; Jones, SB; Leone, SL, 1990
)
0.28
" Cumulative dose-response curves of the alpha 1-agonists l-phenylephrine or cirazoline applied luminally in rat tail arteries and in side branches of canine femoral arteries were identical to those obtained by adventitial application in the intact arteries, and were not modified by removal of the endothelium (eliminating acetylcholine-induced dilations)."( Endothelium-mediated dilations contribute to the polarity of the arterial wall in vasomotion induced by alpha 2-adrenergic agonists.
Busse, R; Holtz, J; Kuon, E; Matsuda, H,
)
0.13
" Dose-response curves to 5-bromo-6-(2-imidazoline-2-yl-amino)quinoxaline (UK 14,304) an alpha-2 adrenergic agonist, were generated in the absence and presence of three concentrations of various antagonists."( Alpha-2A and alpha-2B adrenergic receptor subtypes: attenuation of cyclic AMP production in cell lines containing only one receptor subtype.
Bylund, DB; Ray-Prenger, C, 1989
)
0.28
" A U-shaped dose-response curve to compounds with mixed alpha 2- and alpha 1-antagonist properties may be constructed, which emphasizes the importance of the dose-dependent selectivity of these antagonists at alpha 2- and alpha 1-receptors."( Human vascular smooth muscle responses mediated by alpha 2 mechanisms in vivo and in vitro.
Calvete, J; Hayes, R; Martin, G; Sever, P; Thom, S, 1985
)
0.27
" Twenty-four hours after a single dose of desipramine (10 mg/kg, intraperitoneally) the inhibitory dose-response curves to either UK 14 304 or desipramine itself did not differ significantly from those seen in control animals, whereas both were displaced significantly to the right after 15 days pretreatment with desipramine."( Effects of desipramine on stimulation-induced contractions of the vas deferens of rats pretreated either chronically with desipramine or acutely with idazoxan.
Doxey, JC; Roach, AG; Samuel, J, 1985
)
0.27
" Although administered in a dosage range 100 to 1000 times that of alpha-1 agonists, the alpha-2 agonists (B-HT 920, UK 14,304 and guanabenz) produced only minimal renal vasoconstriction before systemic pressor effects."( In vivo assessment of rat renal alpha adrenoceptors.
Gesek, FA; Strandhoy, JW; Wolff, DW, 1987
)
0.27
"1 mg/kg) and of yohimbine (1 mg/kg) on the dose-response curves for cirazoline in the pithed rat, and for phenylephrine in the anaesthetized dog were compared, after various doses of phenoxybenzamine."( Loss of selectivity of so-called selective alpha 1-adrenoceptor agonists after phenoxybenzamine.
Gonçalves, J; Guimarães, S; Nunes, JP; Paiva, MQ, 1988
)
0.27
" In rats treated with the ganglionic blocking agent, pentolinium, nicardipine produced parallel shifts to the right in the dose-response curves for phenylephrine but had no effect on maximal responses to phenylephrine."( Greater vasodepressor sensitivity to nicardipine in spontaneously hypertensive rats (SHR) compared to normotensive rats.
Armstrong, JM; Atkinson, J; Boillat, N; de Rivaz, JC; Fluckiger, JP; Fouda, AK; Piton, MC; Porchet, PA; Sautel, M; Sonnay, M, 1988
)
0.27
", dose of WB-4101 isomer in mg/kg required to produce a 2-fold rightward shift in the dose-response curves of cirazoline and UK-14,304) obtained in vivo from Schild regressions, alpha 1/alpha 2 selectivity ratios were calculated."( Blockade and postjunctional vascular alpha 1- and alpha 2-adrenoceptors in pithed rat by the enantiomers of WB-4101.
Nelson, WL; Ruffolo, RR; Yaden, EL, 1983
)
0.27
" In contrast, the dose-response curves to tiamenidine and clonidine were flatter and bell-shaped with maxima of 30 and 60 min, respectively."( Sleeping times evoked by alpha adrenoceptor agonists in two-day-old chicks: an experimental model to evaluate full and partial agonists at central alpha-2 adrenoceptors.
Cavero, I; Doxey, JC; Roach, AG; Strachan, DA, 1983
)
0.27
" Dose-response curves for the effects on the plasma noradrenaline concentration (stimulated pithed rabbits) were compared with previously obtained dose-response curves for depression of renal sympathetic nerve activity (conscious rabbits)."( Involvement of peripheral presynaptic inhibition in the reduction of sympathetic tone by moxonidine, rilmenidine and UK 14304.
Starke, K; Szabo, B; Urban, R, 1995
)
0.29
" By contrast, phenylephrine-induced dose-response curves in rabbit aorta were largely unaffected by tyrosine kinase inhibitors at 50 microM."( Alpha 2-adrenoceptor-mediated vasoconstriction requires a tyrosine kinase.
Deth, RC; Jinsi, A, 1995
)
0.29
" Dose-response curves were determined for the effects of rilmenidine as well as of the alpha-2 selective agonist UK 14304 [5-bromo-6-(2-imidazolin-2-ylamino)-quinoxaline] on blood pressure, heart rate, renal postganglionic sympathetic nerve activity and the plasma norepinephrine concentration."( Is the sympathoinhibitory effect of rilmenidine mediated by alpha-2 adrenoceptors or imidazoline receptors?
Starke, K; Szabo, B; Urban, R, 1994
)
0.29
" In agonist dose-response studies, WO caused a noncompetitive inhibition of both alpha 1R and alpha 2R responses, but was more potent against alpha 2R."( Effects of wortmannin on alpha-1/alpha-2 adrenergic receptor-mediated contractile responses in rabbit vascular tissues.
Deth, RC; Waen-Safranchik, VI, 1994
)
0.29
"The authors explored the empirical dosing requirement for administration of an alpha 2-adrenoceptor agonist, brimonidine, and determined its efficacy in decreasing elevations in intraocular pressure (IOP) after 360 degrees argon laser trabeculoplasty (ALT)."( The efficacy of brimonidine in decreasing elevations in intraocular pressure after laser trabeculoplasty.
Barnebey, HS; Chen, KS; Cinotti, DJ; Coleman, AL; Hersh, SB; Lewis, RA; Morrison, JC; Robin, AL; Walt, J; Zimmerman, TJ, 1993
)
0.29
"This vehicle-controlled, double-masked, multicenter trial evaluated three dosing regimens of brimonidine."( The efficacy of brimonidine in decreasing elevations in intraocular pressure after laser trabeculoplasty.
Barnebey, HS; Chen, KS; Cinotti, DJ; Coleman, AL; Hersh, SB; Lewis, RA; Morrison, JC; Robin, AL; Walt, J; Zimmerman, TJ, 1993
)
0.29
" There was little difference in efficacy between the three dosing regimens of brimonidine."( The efficacy of brimonidine in decreasing elevations in intraocular pressure after laser trabeculoplasty.
Barnebey, HS; Chen, KS; Cinotti, DJ; Coleman, AL; Hersh, SB; Lewis, RA; Morrison, JC; Robin, AL; Walt, J; Zimmerman, TJ, 1993
)
0.29
" Prazosin (10(-8) M - 10(-5) M) displaced agonist dose-response curves to the right."( Characterization of alpha-adrenoceptor subtype(s) mediating vasoconstriction in the perfused rabbit ovarian vascular bed.
Oriowo, MA; Williams, KI; Yousif, M, 1996
)
0.29
" Changes in vessel internal diameter were measured and dose-response curves (DRC) for each vasoactive agent were determined."( Nitric oxide inhibition simulates the enhancement of alpha 1 agonist-induced vasoconstriction in diabetes.
Dresner, LS; Mueller, CM; Ponomarenko, IN; Wait, RB; Wang, SP; West, MW, 1997
)
0.3
" Yohimbine pretreatment resulted in a rightward shift of the dose-response curves (DMET > CLON > UK)."( Pharmacological evidence for different alpha 2-adrenergic receptor sites mediating analgesia and sedation in the rat.
Buerkle, H; Yaksh, TL, 1998
)
0.3
" When dosed according to labeling, latanoprost had the lowest cost of therapy at $0."( Daily cost of newer glaucoma agents.
Hudgins, AC; Pruitt, CA; Sine, C; Stewart, WC, 1999
)
0.3
"This study suggests latanoprost dosed daily in the evening statistically reduces intraocular pressure more during daytime and evening hours than brimonidine dosed twice daily."( The efficacy and safety of latanoprost 0.005% once daily versus brimonidine 0.2% twice daily in open-angle glaucoma or ocular hypertension.
Day, DG; Latham, KE; Schuhr, J; Stewart, JA; Stewart, WC, 2001
)
0.31
" Brimonidine reduced the rate of RGC loss in the calibrated rat optic nerve injury model even when dosed 12 and 24 hours before injury, consistent with a long-term enhancement of RGC resistance to stress."( Role of alpha-2 adrenergic receptors in neuroprotection and glaucoma.
Gil, DW; Wheeler, LA; WoldeMussie, E, 2001
)
0.31
" Each treatment period consisted of 6 weeks of chronic dosing followed by a diurnal curve for the intraocular pressure measured at 08:00, 10:00, 16:00, 18:00, 20:00, 22:00, and 24:00 hours."( Brimonidine 0.2% given two or three times daily versus timolol maleate 0.5% in primary open-angle glaucoma.
Holmes, KT; Konstas, AG; Stangos, NT; Stewart, WC; Tersis, I; Topouzis, F, 2001
)
0.31
") caused dose-dependent rightward shift in the pressor dose-response curve induced by B-HT 920."( alpha(2)-adrenoceptor antagonist properties of OPC-28326, a novel selective peripheral vasodilator.
Hashimoto, A; Imaizumi, T; Kambe, T; Kishi, M; Mori, T; Nakazawa, T; Orito, K, 2001
)
0.31
" Single and multiple dosing led to a similar drug distribution, with higher levels of brimonidine measured in pigmented tissues after multiple dosing."( Distribution of brimonidine into anterior and posterior tissues of monkey, rabbit, and rat eyes.
Acheampong, AA; Burke, J; John, B; Shackleton, M; Tang-Liu, D; Wheeler, L, 2002
)
0.31
"The purpose of this study was to investigate the dose-response effects of topically administered brimonidine (BMD) on retinal ganglion cell (RGC) survival, short and long periods of time after transient retinal ischemia."( Neuroprotective effects of brimonidine against transient ischemia-induced retinal ganglion cell death: a dose response in vivo study.
Aguilera, ME; Lafuente, MP; Mayor, S; Miralles de Imperial, J; Vidal-Sanz, M; Villegas-Pérez, MP, 2002
)
0.31
" In fetal, but not adult, MCA, UK-14304 induced a significant decrease in pD(2) for the phenylephrine dose-response relation."( Pre- and postjunctional alpha(2)-adrenergic receptors in fetal and adult ovine cerebral arteries.
Bishai, JM; Buchholz, JN; Gheorghe, CP; Longo, LD; Meulenaar, R; Nijland, R; Penninga, L; Zhang, L; Zhao, Y, 2002
)
0.31
"A single dosage of brimonidine tartrate ophth solution (0."( Up-regulation of brain-derived neurotrophic factor expression by brimonidine in rat retinal ganglion cells.
Cantor, LB; Gao, H; Qiao, X; WuDunn, D, 2002
)
0.31
"The subjects in this prospective, double-masked, crossover comparison were dosed 15 min prior to treadmill testing."( Cardiovascular effects of timolol maleate, brimonidine or brimonidine/timolol maleate in concomitant therapy.
Jackson, AL; Stewart, JA; Stewart, WC, 2002
)
0.31
"Rates of medication discontinuation reflect factors including effectiveness, tolerability, cost, and dosing frequency."( Discontinuation rates of topical glaucoma medications in a managed care population.
Cho, J; Mullins, CD; Shaya, FT; Wong, W, 2002
)
0.31
" AGN192403, a selective ligand at I1-R, had no influence on the dose-response curve of moxonidine (log EC50: -6."( Presynaptic effects of moxonidine in isolated buffer perfused rat hearts: role of imidazoline-1 receptors and alpha2-adrenoceptors.
Burgdorf, C; Engelhardt, A; Kurz, T; Richardt, G; Schäfer, U, 2002
)
0.31
" Clinical dosing of the topical formulation of brimonidine results in brimonidine concentrations in the posterior segment that are sufficient for both pharmacological activity at alpha-2 adrenergic receptors and neuroprotection."( Role of alpha-2 agonists in neuroprotection.
Lai, R; Wheeler, L; WoldeMussie, E, 2003
)
0.32
" Children are at greater risk for systemic side effects because ocular dosing is not weight-adjusted, and infants are especially vulnerable as a consequence of the inability to efficiently metabolize the drug, and/or an immature blood-brain barrier."( Systemic side effects of ophthalmic drops.
Levy, Y; Zadok, D,
)
0.13
" However, unoprostone, but not brimonidine, decreased IOP over the complete 12-hour daytime dosing cycle."( The safety and efficacy of unoprostone 0.15% versus brimonidine 0.2%.
Day, DG; Jenkins, J; Stewart, JA; Stewart, WC, 2004
)
0.32
"Fixed combination latanoprost/timolol administered once daily is both more effective and better tolerated than twice daily dosing with UFC brimonidine/timolol."( A comparison of the fixed combination of latanoprost and timolol with the unfixed combination of brimonidine and timolol in patients with elevated intraocular pressure. A six month, evaluator masked, multicentre study in Europe.
Cunliffe, I; García-Sánchez, J; Landry, J; Pajic, B; Rouland, JF; Spiegel, D; Traverso, C, 2004
)
0.32
" Intraocular pressure (IOP) was measured at 08:00 (trough) and 10:00, 18:00, and 20:00 hours after dosing at each baseline and at the end of each treatment period."( Brimonidine purite 0.15% versus dorzolamide 2% each given twice daily to reduce intraocular pressure in subjects with open angle glaucoma or ocular hypertension.
Beischel, CJ; Day, DG; Rhodes, JS; Sharpe, ED; Stewart, JA; Stewart, WC, 2004
)
0.32
" Topical brimonidine purite in this dosage was unsuccessful in preventing second eye involvement in recently monocularly-symptomatic LHON."( Prophylaxis for second eye involvement in leber hereditary optic neuropathy: an open-labeled, nonrandomized multicenter trial of topical brimonidine purite.
Bhatti, MT; Biousse, V; Chen, K; David, R; Farris, BK; Hamilton, SR; Keaney, RP; Lesser, RL; Newman, NJ; Newman, SA; Turbin, RE, 2005
)
0.33
" IOP was assessed pre-dose and 2 hours after morning dosing at weeks 2, 6, and 12."( 12-week study comparing the fixed combination of brimonidine and timolol with concomitant use of the individual components in patients with glaucoma and ocular hypertension.
Goñi, FJ,
)
0.13
" Its simplified dosing regimen has the potential to improve compliance."( 12-week study comparing the fixed combination of brimonidine and timolol with concomitant use of the individual components in patients with glaucoma and ocular hypertension.
Goñi, FJ,
)
0.13
" Brimonidine is not dosed by weight and therefore paediatric patients may be at increased risk for systemic toxicity."( Is brimonidine ophthalmic a safe therapy for infants?
Daubert, GP, 2006
)
0.33
"15% preserved with chlorine dioxide (brimonidine P) dosed 3 times daily and were followed up for 6 months."( The safety and intraocular pressure-lowering efficacy of brimonidine tartrate 0.15% preserved with polyquaternium-1.
Andrew, RM; Bergamini, MV; Bosworth, CF; Dickerson, JE; James, JE; Landry, TA; Moster, MR; Ochsner, KI; Silver, LH; Sullivan, EK; Wells, DT; Whitson, JT, 2006
)
0.33
"To evaluate the 24-h intraocular pressure (IOP) control of brimonidine/timolol fixed combination (BTFC) versusthe unfixed combination of its individual components, each dosed twice daily, in patients with primary open-angle glaucoma or ocular hypertension."( Twenty-four-hour efficacy of the brimonidine/timolol fixed combination versus therapy with the unfixed components.
Georgiadou, I; Kaltsos, K; Katsimpris, IE; Konstas, AG; Kordelou, A; Nelson, LA; Stewart, WC, 2008
)
0.35
"15%, both dosed twice a day for 4 weeks."( Brimonidine 0.2% versus brimonidine Purite 0.15% in Asian ocular hypertension.
Hong, S; Kim, CY; Seong, GJ, 2007
)
0.34
" For prostaglandins, dosing time was suggested in the morning by 18 (36%) ophthalmologists and in the evening by 24 (48%) (p=0."( Ophthalmologist attitudes regarding fixed combination treatment for glaucoma in the European Union.
Kruft, B; Nelson, LA; Stewart, JA; Stewart, WC,
)
0.13
" However, the fixed dosing may be a disadvantage in some cases."( Fixed combinations of dorzolamide-timolol and brimonidine-timolol in the management of glaucoma.
Katz, LJ; Razeghinejad, MR; Sawchyn, AK, 2010
)
0.36
" In-vivo experiments showed that it was possible to prolong the drug release over a period of 8 hr, on topical instillation of BT loaded nanoparticles to albino rabbits, hence reducing the dosage frequency."( Development and Evaluation of Novel Polymeric Nanoparticles of Brimonidine Tartrate.
Shinde, UA; Singh, KH, 2010
)
0.36
" In 65 patients (97%), at least 1 dosing interval exceeded 24 hours."( Measurement of adherence to brimonidine therapy for glaucoma using electronic monitoring.
Bron, AM; Creuzot-Garcher, CP; Diestelhorst, M; Hermann, MM, 2011
)
0.37
"To assess the impact of open versus masked adherence monitoring on adherence with topical brimonidine using two different dosing schedules."( Adherence with brimonidine in patients with glaucoma aware and not aware of electronic monitoring.
Diestelhorst, M; Georgopoulos, G; Hermann, MM; Muether, PS; Papaconstantinou, D, 2011
)
0.37
" Adherence calculations comprised dosing intervals, adherence rate and time covered."( Adherence with brimonidine in patients with glaucoma aware and not aware of electronic monitoring.
Diestelhorst, M; Georgopoulos, G; Hermann, MM; Muether, PS; Papaconstantinou, D, 2011
)
0.37
" Hence, the lyophilized vesicles, when dispersed in viscous carbopol solution, had the potential in reducing dosing frequency and could improve patient compliance."( Nanovesicular formulation of brimonidine tartrate for the management of glaucoma: in vitro and in vivo evaluation.
Maiti, S; Mondol, R; Paul, S; Ray, S; Sa, B, 2011
)
0.37
" These results suggest that BT loaded CS nanoparticles could help to reduce dosage frequency by sustained drug release in the treatment of glaucoma."( Chitosan nanoparticles for controlled delivery of brimonidine tartrate to the ocular membrane.
Shinde, UA; Singh, KH, 2011
)
0.37
"The poor bioavailability and therapeutic response exhibited by conventional eye drops due to rapid precorneal elimination of the drug may be overcome by the use of an in situ gelling systems that are instilled as drops into the eye and undergo a sol-to-gel transition in the cul-de-sac which improves patient compliance as the dosage regimen is one drop of the dosage form twice a day."( Sustained ocular delivery of brimonidine tartrate using ion activated in situ gelling system.
Geethalakshmi, A; Jha, SK; Karki, R; Nikunj, B; Venkatesh, DP, 2012
)
0.38
"005% (n = 75, dosed in the evening, with vehicle control in the morning to maintain masking) for 12 weeks."( Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study.
Cottingham, AJ; Hollander, DA; Katz, LJ; Rauchman, SH; Schiffman, RM; Simmons, ST; Williams, JM, 2012
)
0.38
" Based on the optimized formulation, triple-layered ocular inserts (reservoir type) of dual drug were prepared by solvent casting technique with an objective of reducing the frequency of administration, obtaining controlled release and greater therapeutic efficacy, preservative free dosage form for the treatment of glaucoma."( Chick chorioallantoic membrane model for in ovo evaluation of timolol maleate-brimonidine tartrate ocular inserts.
Appapurapu, AK; Ravindran, VK; Repala, S; Subadhra, S, 2014
)
0.4
" Brimonidine tartrate (BT), a common glaucoma medication, requires dosing every 8-12 h, with up to 97% of patients not taking it as prescribed."( 28-day intraocular pressure reduction with a single dose of brimonidine tartrate-loaded microspheres.
Conner, IP; Fedorchak, MV; Little, SR; Medina, CA; Schuman, JS; Wingard, JB, 2014
)
0.4
"2% monotherapy, all dosed 2 times per day (BID)."( Twice-daily brinzolamide/brimonidine fixed combination versus brinzolamide or brimonidine in open-angle glaucoma or ocular hypertension.
Aung, T; Branch, JD; Goldberg, I; Hernandez Paredes, TJ; Laganovska, G; Tsorbatzoglou, A, 2014
)
0.4
" Thus, the developed nanobrimonidine has the potential to improve the efficacy, reduce dosage and frequency, and improve delivery to the anterior chamber of the eye."( Effect of Ultra-Small Chitosan Nanoparticles Doped with Brimonidine on the Ultra-Structure of the Trabecular Meshwork of Glaucoma Patients.
Barwal, I; Dada, T; Kumar, R; Yadav, SC, 2019
)
0.51
"Timolol is a non-cardioselective beta blocker and has different combined ophthalmic dosage forms for treatment of glaucoma."( A versatile HPLC method with an isocratic single mobile phase system for simultaneous determination of anti-glaucoma formulations containing timolol.
El Abass, SA; Elmansi, HM; Ibrahim, FA, 2019
)
0.51
" Among the latter, a dose-response phenomenon is evident."( A review of neuropsychiatric adverse events from topical ophthalmic brimonidine.
Cimolai, N, 2020
)
0.56
" Significant improvements in near vision were observed only during the 1-2 h period after dosing when miosis peaked."( Time-course of the visual Impact on presbyopes of a low dose miotic.
Bradley, A; Dibas, M; Gil, D; Kollbaum, P; Meyer, D; Perron, L; Rickert, M; Xu, R, 2021
)
0.62
" For many chronic ocular diseases, patient adherence to eye drop dosing regimens and the need for frequent intraocular injections are significant barriers to effective disease management."( Machine learning-driven multifunctional peptide engineering for sustained ocular drug delivery.
Anders, NM; Appell, MB; Chou, RT; Cummings, MP; Davison, C; Edwards, M; Ensign, LM; Hanes, J; Hemingway, A; Hsueh, HT; Kim, YC; Kolodziejski, P; Kwon, H; Leo, KT; Liyanage, W; Mozzer, A; Pejavar, J; Pitha, I; Rai, U; Rompicharla, SVK; Sista, M, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,501)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990135 (8.99)18.7374
1990's452 (30.11)18.2507
2000's462 (30.78)29.6817
2010's348 (23.18)24.3611
2020's104 (6.93)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials282 (17.89%)5.53%
Reviews85 (5.39%)6.00%
Case Studies124 (7.87%)4.05%
Observational2 (0.13%)0.25%
Other1,083 (68.72%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (160)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Changes in Peripapillary Blood Flow After Use of Anti-glaucoma Medications: A Prospective, Quantitative OCT Angiography Study [NCT03323164]Phase 435 participants (Actual)Interventional2017-07-10Completed
A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma [NCT03193333]Phase 351 participants (Anticipated)Interventional2017-11-06Recruiting
Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea [NCT03048058]Phase 420 participants (Actual)Interventional2016-05-05Completed
Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome [NCT03760185]Phase 213 participants (Actual)Interventional2019-01-04Completed
Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature [NCT01201551]40 participants (Actual)Interventional2011-06-30Completed
A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED) [NCT03785340]Phase 3252 participants (Actual)Interventional2018-12-03Completed
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED) [NCT03418727]Phase 284 participants (Actual)Interventional2017-09-06Completed
Clinical Study to Evaluate the Non-inferiority of PRO-122 an Ophthlamic Solution Manufactured by Laboratorios Sophia, Previous Treatment With Krytantek Ofteno ®, in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension. [NCT03257813]Phase 360 participants (Actual)Interventional2016-04-01Completed
Circadian Rhythms of Aqueous Humor Dynamics in Subjects With Ocular Hypertension Using Brimonidine [NCT01144494]Early Phase 135 participants (Actual)Interventional2010-08-01Completed
Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents [NCT02140450]70 participants (Actual)Interventional2012-02-29Completed
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects [NCT03139708]Phase 15 participants (Actual)Interventional2016-09-30Completed
Effect of Brimonidine on Corneal Thickness [NCT01250236]10 participants (Anticipated)Observational2010-12-31Recruiting
[NCT01284166]Phase 30 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to Study was never initiated due to company decision. No study subjects were ever enrolled or treated.)
Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma [NCT03966560]Phase 496 participants (Actual)Interventional2014-01-31Completed
A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease [NCT03591874]Phase 359 participants (Actual)Interventional2018-12-23Terminated(stopped due to Primary endpoint was not met.)
Treatment of Asian Flushing Syndrome With Topical Alpha Agonists [NCT03497442]Early Phase 120 participants (Actual)Interventional2018-07-12Completed
Efficacy and Necessity of Time Interval Between Instillation of Two Glaucoma Eye Drops [NCT03220490]65 participants (Anticipated)Interventional2017-11-01Recruiting
Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension [NCT01062971]Phase 2124 participants (Actual)Interventional2006-02-28Completed
24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle [NCT02770248]Phase 4162 participants (Actual)Interventional2016-05-23Completed
Mirvaso® Utilisation and Patient Satisfaction Evaluation [NCT02637232]301 participants (Actual)Observational2015-10-31Completed
A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy With Carbachol Topical Ophthalmic Solution in Subjects Wit [NCT04774237]Phase 281 participants (Actual)Interventional2021-03-24Completed
[NCT03508869]5 participants (Actual)Interventional2016-09-27Terminated(stopped due to sponsor asked site to suspend study.)
The Effect of Topical Brimonidine on the Hemodynamics of the Optic Nerve Head and Retinochoroidal Circulation in Patients of Primary Open Angle Glaucoma Using Optical Coherence Tomography Angiography [NCT05474716]Phase 441 participants (Actual)Interventional2020-05-01Completed
Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy [NCT01345448]Phase 222 participants (Anticipated)Interventional2011-04-30Recruiting
Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents [NCT03513172]55 participants (Actual)Interventional2016-12-15Completed
Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma [NCT01310777]Phase 3771 participants (Actual)Interventional2011-05-31Completed
A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Thr [NCT01297920]Phase 31,062 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
Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism [NCT00712777]0 participants (Actual)Interventional2008-03-31Withdrawn
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma [NCT04205201]Phase 280 participants (Actual)Interventional2018-06-25Completed
Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs [NCT00675207]Phase 4120 participants (Actual)Interventional2006-01-31Completed
[NCT00822055]Phase 4140 participants (Actual)Interventional2005-05-31Completed
Safety and IOP-Lowering Efficacy of Brinzolamide/Brimonidine Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma and/or Ocular Hypertension [NCT00961649]Phase 2195 participants (Actual)Interventional2009-10-31Terminated
Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients. [NCT04702789]Phase 428 participants (Actual)Interventional2021-10-19Terminated(stopped due to For interests of sponsor.)
Efficacy and Safety of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension [NCT02339584]Phase 3493 participants (Actual)Interventional2015-04-14Completed
Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma [NCT00981786]Phase 451 participants (Actual)Interventional2009-08-31Completed
Comparison of Selective Laser Trabeculoplasty With Prostaglandin Analogues for Lowering Intraocular Pressure in Eyes With Primary Angle Closure Glaucoma [NCT01004900]Phase 390 participants (Anticipated)Interventional2009-06-30Recruiting
Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery [NCT00800423]Phase 3150 participants (Anticipated)Interventional2009-01-31Not yet recruiting
The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1% [NCT04007276]Phase 460 participants (Anticipated)Interventional2025-11-10Not yet recruiting
[NCT00651612]Phase 3604 participants (Actual)Interventional2005-11-30Completed
Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms [NCT05006898]Phase 111 participants (Actual)Interventional2020-06-01Completed
Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinicall [NCT03966365]Phase 124 participants (Actual)Interventional2019-05-02Completed
Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma [NCT00972257]Phase 464 participants (Actual)Interventional2009-01-31Completed
Randomized, Investigator Masked Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glau [NCT00698945]Phase 440 participants (Anticipated)Interventional2008-06-30Completed
A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea [NCT02602470]206 participants (Actual)Observational2015-01-08Completed
Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma [NCT00800540]Phase 435 participants (Actual)Interventional2009-02-28Completed
Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE) [NCT02568111]Phase 40 participants (Actual)Interventional2016-02-29Withdrawn
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Mult [NCT04647461]Phase 461 participants (Actual)Interventional2019-03-20Active, not recruiting
[NCT01217606]Phase 3185 participants (Actual)Interventional2011-01-31Completed
[NCT00652483]Phase 3433 participants (Actual)Interventional2003-05-31Completed
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results [NCT00804921]Phase 20 participants InterventionalCompleted
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection [NCT00864838]Phase 256 participants (Actual)Interventional2008-06-30Completed
[NCT00822081]Phase 4140 participants (Actual)Interventional2005-01-31Completed
A Prospective Study to Evaluate the Effect of Preoperative Topical Brimonidine Tartrate 0.2% (Allergan, Irvine, CA) on Intraocular Pressure (IOP) of Patients Undergoing Robot-assisted Laparoscopic Prostatectomy (RALP) [NCT02818816]Phase 426 participants (Actual)Interventional2016-02-29Completed
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects [NCT03959176]Phase 413 participants (Actual)Interventional2019-07-20Completed
[NCT00168363]Phase 3207 participants (Actual)Interventional2005-01-31Completed
Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study [NCT01887223]Phase 240 participants (Actual)Interventional2010-05-31Completed
[NCT00413751]20 participants ObservationalCompleted
Three Month Efficacy and Safety Study of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension [NCT01297517]Phase 31,001 participants (Actual)Interventional2011-02-28Completed
A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel (5 mg/g Brimonidine Tartrate) in Patients With Chronic Persistent Vascular Facial Erythema. [NCT02856919]Phase 4101 participants (Actual)Interventional2016-06-13Completed
A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia [NCT05431543]Phase 258 participants (Actual)Interventional2022-08-06Completed
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty [NCT00567411]43 participants (Anticipated)Interventional2006-08-31Recruiting
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension [NCT03450629]Phase 3682 participants (Actual)Interventional2018-09-13Completed
The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter [NCT02214680]Phase 225 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN- PLUS® Eye Drops and COMBIGAN® Eye Drops in Glaucoma or Ocular Hypertensive Patients [NCT06078592]Phase 460 participants (Actual)Interventional2021-10-08Completed
[NCT00652106]Phase 3432 participants (Actual)Interventional2003-06-30Completed
Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations: A Prospective, Open-label, Cohort Study [NCT02764411]Phase 36 participants (Actual)Interventional2016-06-30Terminated(stopped due to Poor enrollment, lack of feasibility)
The Effect of Reducing the Intraocular Pressure by Using Alphagan Drops and Macular Edema in Patients With Diabetic Macular Edema [NCT02718547]25 participants (Anticipated)Interventional2017-03-26Recruiting
Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias [NCT02761174]Phase 419 participants (Actual)Interventional2016-03-13Completed
A Double-masked Randomized Cross-over Study Comparing of the Effect of Xalacom® (Latanoprost/Timolol)and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular [NCT00706927]16 participants (Actual)Interventional2006-01-31Completed
Effect of Brimonidine 0.15% on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Tension Glaucoma [NCT01105065]46 participants (Actual)Interventional2010-03-31Completed
[NCT00332345]Phase 273 participants (Actual)Interventional1999-07-31Completed
Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2% [NCT01417858]50 participants (Anticipated)Interventional2010-11-30Recruiting
The Effect if Brimonidine 0.15% on the Development of Subconjunctival Hemorrhage Following Femtosecond Laser Assisted Cataract Surgery [NCT04633954]56 participants (Actual)Interventional2019-06-06Completed
Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model [NCT05579730]Phase 3187 participants (Actual)Interventional2022-11-18Completed
Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial. [NCT00466479]Phase 450 participants Interventional1999-08-31Completed
[NCT00440141]Phase 440 participants (Actual)Interventional2006-07-31Completed
Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension [NCT01309204]Phase 31,184 participants (Actual)Interventional2011-05-31Completed
[NCT01241240]Phase 3192 participants (Actual)Interventional2011-03-31Completed
[NCT01229410]Phase 124 participants (Actual)Interventional2010-12-31Completed
The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy [NCT01255306]60 participants (Actual)Observational2010-04-30Completed
The Effect of Brimonidine Tartrate on Subconjunctival Hemorrhage During Pterygium Surgery [NCT04683159]66 participants (Anticipated)Interventional2021-02-28Not yet recruiting
Evaluation of the Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle in an Allergen BioCube® in Subjects With Seasonal Allergic Conjunctivitis [NCT05591755]Phase 3228 participants (Actual)Interventional2022-10-22Completed
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia [NCT05135286]Phase 3450 participants (Anticipated)Interventional2022-03-15Recruiting
[NCT01151904]Phase 417 participants (Actual)Interventional2009-11-30Terminated(stopped due to Difficulty with patient recruitment)
A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers [NCT02967614]Phase 132 participants (Actual)Interventional2016-12-31Completed
INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE [NCT00347035]Phase 40 participants InterventionalTerminated
Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial [NCT00435058]54 participants Interventional2005-09-30Completed
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost [NCT00348400]Phase 40 participants InterventionalCompleted
Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients. [NCT00352807]22 participants Interventional2005-02-28Completed
Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide/Brimonidine Ophthalmic Suspension 1% to Simbrinza® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes [NCT04944290]Phase 3447 participants (Actual)Interventional2021-05-28Completed
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia [NCT05270863]Phase 3182 participants (Actual)Interventional2022-03-30Completed
[NCT00332384]Phase 3573 participants (Actual)Interventional2000-01-31Completed
The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height [NCT03782701]Phase 443 participants (Actual)Interventional2019-06-18Completed
Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves [NCT01535768]Phase 4150 participants (Anticipated)Interventional2012-02-29Recruiting
A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Mon [NCT00121147]200 participants Interventional2003-09-30Completed
Effects of Common Topical Glaucoma Therapy on Optic Nerve Head Blood Flow Autoregulation During Increased Arterial Blood Pressure and Artificially Elevated Intraocular Pressure in Healthy Humans [NCT00275756]0 participants (Actual)Interventional2008-09-30Withdrawn
A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost. [NCT00402493]51 participants (Actual)Interventional2006-12-31Completed
A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension [NCT00061529]Phase 30 participants Interventional2003-01-31Completed
[NCT00457795]Phase 415 participants (Actual)Interventional2006-12-31Completed
[NCT00693485]Phase 270 participants (Actual)Interventional2008-09-30Completed
A Phase II, Single-Center, Two-Way Crossover Relative Systemic Bioavailability Study of Col-118 Administered Topically as a 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2% Administered to the Eye in Subjects With Moderate to Severe Erythematous [NCT00697541]Phase 220 participants (Actual)Interventional2008-05-31Completed
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD [NCT00658619]Phase 2119 participants (Actual)Interventional2008-05-01Completed
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects [NCT00735449]Phase 4204 participants (Actual)Interventional2008-07-31Completed
Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy [NCT01726075]Phase 2/Phase 3450 participants (Actual)Interventional2013-02-28Completed
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma [NCT00869141]Phase 452 participants (Actual)Interventional2009-03-31Completed
[NCT01987752]732 participants (Actual)Observational2009-01-31Completed
[NCT02385240]Phase 3552 participants (Actual)Interventional2015-03-31Completed
A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia [NCT05936489]Phase 130 participants (Actual)Interventional2023-07-06Completed
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution, Used Two Times Daily in Healthy Adult [NCT05815758]511 participants (Actual)Observational2023-04-20Completed
A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension [NCT01687426]Phase 115 participants (Actual)Interventional2012-09-30Completed
A Multicenter, Double-Masked, 2-Arm Parallel Group Study Comparing the Effect of Brimonidine 0.2% Versus Timolol 0.5% on Visual Field Stability in Patients With Low-Pressure Glaucoma [NCT00317577]Phase 2160 participants Interventional1998-12-31Completed
[NCT00332436]Phase 3586 participants (Actual)Interventional1999-12-31Completed
Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise [NCT00312416]Phase 418 participants Interventional2004-02-29Completed
Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination As Adjunctive Therapy to Travoprost [NCT01937299]Phase 4307 participants (Actual)Interventional2013-10-31Completed
Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects [NCT05753189]Phase 3361 participants (Actual)Interventional2023-02-21Active, not recruiting
A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia [NCT05728944]Phase 3229 participants (Actual)Interventional2023-04-24Active, not recruiting
A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia [NCT05656027]Phase 3469 participants (Actual)Interventional2022-12-19Active, not recruiting
[NCT01170884]Phase 4121 participants (Actual)Interventional2009-12-31Completed
Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea [NCT01885000]Phase 392 participants (Actual)Interventional2013-07-01Completed
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia [NCT06045299]Phase 3300 participants (Anticipated)Interventional2023-09-27Recruiting
[NCT01229462]238 participants (Actual)Interventional2010-10-31Completed
Randomized, Multicenter, Open-label, Parallel Group Study to Evaluate Efficacy and Safety of Combigan(Brimonidine/Timolol) and 0.5% Timoptic(Timolol) Ophthalmic Solutions in Normal Tension Glaucoma Patients [NCT01446497]Phase 422 participants (Anticipated)Interventional2010-10-31Recruiting
Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy [NCT03192826]Phase 479 participants (Actual)Interventional2016-06-20Completed
A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With No [NCT03150160]Phase 41 participants (Actual)Interventional2017-09-21Completed
A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hype [NCT01426867]Phase 2103 participants (Actual)Interventional2011-09-30Completed
MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study) [NCT02249065]Phase 4205 participants (Actual)Interventional2014-09-30Completed
[NCT01525173]Phase 4137 participants (Actual)Interventional2012-01-31Completed
A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea [NCT01659853]Phase 370 participants (Actual)Interventional2012-09-30Completed
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study [NCT02147691]Phase 422 participants (Actual)Interventional2014-05-31Completed
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration [NCT02087085]Phase 2310 participants (Actual)Interventional2014-05-09Terminated
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects [NCT01959243]Phase 3507 participants (Actual)Interventional2014-02-22Completed
A Phase I/II Randomized, Placebo-Controlled, Double-Blind, Single-Center, Tolerability And Preliminary Efficacy Study Of Use of Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD) [NCT02975557]Phase 1/Phase 215 participants (Actual)Interventional2016-05-31Terminated(stopped due to Slow accrual of subjects. May take longer than expected to complete the trial.)
Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals [NCT05001243]Phase 111 participants (Anticipated)Interventional2021-08-10Recruiting
A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects. [NCT02039765]Phase 112 participants (Actual)Interventional2014-02-28Completed
Half-Side Controlled Analysis of the Effect of Topical Brimonidine Tartrate on the Frequency and Severity of Hand-Foot Syndrome (HFS) in Cancer Patients Receiving Antineoplastic Agents (BRIMOCAN) [NCT03173365]Phase 22 participants (Actual)Interventional2017-07-10Terminated(stopped due to It is no longer practicable to complete the trial)
[NCT00661479]Phase 1/Phase 221 participants (Actual)Interventional2008-07-31Completed
[NCT00972374]Phase 244 participants (Actual)Interventional2009-11-30Completed
[NCT00811564]Phase 4148 participants (Actual)Interventional2008-12-31Completed
Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG) [NCT00824824]21 participants (Actual)Interventional2009-01-31Completed
[NCT01863953]Phase 2112 participants (Actual)Interventional2013-06-30Completed
Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia [NCT05006911]Phase 111 participants (Anticipated)Interventional2021-08-14Recruiting
Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery [NCT05480098]Phase 4100 participants (Anticipated)Interventional2022-05-26Recruiting
A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia [NCT05294328]Phase 262 participants (Actual)Interventional2022-05-05Completed
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
[NCT00811850]Phase 415 participants (Actual)Interventional2008-12-31Completed
[NCT02003534]Phase 4376 participants (Actual)Interventional2010-07-31Completed
Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue [NCT01937312]Phase 4282 participants (Actual)Interventional2013-10-31Completed
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Re [NCT01959230]Phase 360 participants (Actual)Interventional2013-11-07Completed
Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors [NCT04523844]47 participants (Actual)Interventional2020-05-11Completed
Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses [NCT03825081]Early Phase 133 participants (Anticipated)Interventional2019-01-21Recruiting
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification [NCT03494257]62 participants (Actual)Interventional2017-09-04Completed
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (Brimonidine) Topical [NCT02289352]Phase 3462 participants (Actual)Interventional2014-07-31Completed
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
Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) [NCT02730871]Phase 4173 participants (Actual)Interventional2016-06-24Terminated(stopped due to Enrollment Challenges)
The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness [NCT05360784]Phase 3380 participants (Actual)Interventional2022-05-13Completed
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC) [NCT01275105]Phase 268 participants (Actual)Interventional2011-01-31Completed
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects [NCT01675609]Phase 257 participants (Actual)Interventional2012-08-31Completed
Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy [NCT01978600]Phase 489 participants (Actual)Interventional2013-10-31Completed
Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea [NCT02616250]Phase 4190 participants (Actual)Interventional2015-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00457795 (4) [back to overview]Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
NCT00457795 (4) [back to overview]Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
NCT00457795 (4) [back to overview]Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
NCT00457795 (4) [back to overview]Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
NCT00658619 (5) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
NCT00658619 (5) [back to overview]Change From Baseline in Contrast Sensitivity in the Study Eye
NCT00658619 (5) [back to overview]Change From Baseline in Reading Speed in the Study Eye
NCT00658619 (5) [back to overview]Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
NCT00658619 (5) [back to overview]Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
NCT00661479 (2) [back to overview]Change From Baseline in Contrast Sensitivity in the Study Eye
NCT00661479 (2) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
NCT00693485 (2) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
NCT00693485 (2) [back to overview]Percentage of Patients With a Visual Field Improvement in the Study Eye
NCT00697541 (3) [back to overview]Tmax - Time to Maximum Plasma Concentration
NCT00697541 (3) [back to overview]Cmax - Maximum Systemic Concentration of Brimonidine
NCT00697541 (3) [back to overview]AUC - Area Under the Curve of Brimonidine
NCT00735449 (5) [back to overview]Mean Intraocular Pressure (IOP) at 8 AM at Week 12
NCT00735449 (5) [back to overview]Mean Intraocular Pressure (IOP) at 10 AM at Week 12
NCT00735449 (5) [back to overview]Mean Intraocular Pressure (IOP) at 10 AM at Week 6
NCT00735449 (5) [back to overview]Mean Intraocular Pressure (IOP) at 8 AM at Week 6
NCT00735449 (5) [back to overview]Number of Subjects With Adverse Events
NCT00800540 (12) [back to overview]Mean Change From Baseline in Diastolic Blood Pressure at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Systolic Blood Pressure at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
NCT00800540 (12) [back to overview]Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
NCT00800540 (12) [back to overview]Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
NCT00811564 (1) [back to overview]Intraocular Pressure (IOP) at Week 12
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
NCT00811850 (8) [back to overview]Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
NCT00824824 (1) [back to overview]Presence of Retinal Vascular Dysregulation (RVD)
NCT00869141 (3) [back to overview]Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
NCT00869141 (3) [back to overview]Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
NCT00869141 (3) [back to overview]Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma
NCT00961649 (2) [back to overview]Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
NCT00961649 (2) [back to overview]Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
NCT00972374 (3) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
NCT00972374 (3) [back to overview]Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
NCT00972374 (3) [back to overview]Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
NCT01062971 (2) [back to overview]Intraocular Pressure (IOP)
NCT01062971 (2) [back to overview]Number of Adverse Events
NCT01105065 (2) [back to overview]Presence of Retinal Blood Flow Autoregulation
NCT01105065 (2) [back to overview]Frequency Doubling Perimetry
NCT01144494 (5) [back to overview]Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP)
NCT01144494 (5) [back to overview]Outflow Facility
NCT01144494 (5) [back to overview]Uveoscleral Outflow
NCT01144494 (5) [back to overview]Aqueous Flow
NCT01144494 (5) [back to overview]Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm
NCT01170884 (1) [back to overview]Mean Diurnal Intraocular Pressure (IOP) at Week 12
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 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
NCT01217606 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
NCT01229410 (3) [back to overview]Highest Aqueous Humor Level of Brimonidine in the Study Eye
NCT01229410 (3) [back to overview]Highest Vitreous Humor Level of Brimonidine in the Study Eye
NCT01229410 (3) [back to overview]Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)
NCT01229462 (1) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
NCT01241240 (3) [back to overview]Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
NCT01241240 (3) [back to overview]Mean Worse Eye IOP
NCT01241240 (3) [back to overview]Change From Baseline in Mean Worse Eye IOP
NCT01255306 (2) [back to overview]Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade
NCT01255306 (2) [back to overview]Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
NCT01297517 (1) [back to overview]Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
NCT01297920 (1) [back to overview]Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
NCT01309204 (1) [back to overview]Mean Diurnal IOP Change From Baseline at Month 3
NCT01310777 (1) [back to overview]Mean Diurnal IOP Change From Baseline at Month 3
NCT01426867 (1) [back to overview]Mean Ocular Discomfort Score
NCT01525173 (1) [back to overview]Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
NCT01659853 (2) [back to overview]Composite Success
NCT01659853 (2) [back to overview]Onset of Action
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
NCT01885000 (9) [back to overview]EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
NCT01885000 (9) [back to overview]Percentage of Participants With Facial Redness Questionnaire at Day 8
NCT01885000 (9) [back to overview]Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
NCT01885000 (9) [back to overview]Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8
NCT01885000 (9) [back to overview]Number of Participants Reported Adverse Events
NCT01885000 (9) [back to overview]Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
NCT01885000 (9) [back to overview]Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
NCT01885000 (9) [back to overview]Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
NCT01885000 (9) [back to overview]Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
NCT01937299 (3) [back to overview]Mean Diurnal Intraocular Pressure (IOP) at Week 6
NCT01937299 (3) [back to overview]Mean Diurnal IOP Change From Baseline to Week 6
NCT01937299 (3) [back to overview]Mean Diurnal IOP Percentage Change From Baseline to Week 6
NCT01937312 (4) [back to overview]Mean Diurnal Intraocular Pressure (IOP) at Week 6
NCT01937312 (4) [back to overview]Mean Diurnal IOP Change From Baseline to Week 6
NCT01937312 (4) [back to overview]Mean Diurnal IOP Percentage Change From Baseline to Week 6
NCT01937312 (4) [back to overview]Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
NCT01959230 (3) [back to overview]Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale
NCT01959230 (3) [back to overview]Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
NCT01959230 (3) [back to overview]Ocular Redness as Measured by the Participant
NCT01959243 (3) [back to overview]Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
NCT01959243 (3) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT01959243 (3) [back to overview]Drop Comfort Assessment as Assessed by the Participant
NCT01978600 (3) [back to overview]Mean 24-hour IOP at Week 4
NCT01978600 (3) [back to overview]Mean Diurnal IOP at Week 4
NCT01978600 (3) [back to overview]Mean Nocturnal IOP at Week 4
NCT01987752 (2) [back to overview]Percentage of Participants Reporting Adverse Events
NCT01987752 (2) [back to overview]Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)
NCT02003534 (1) [back to overview]Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
NCT02087085 (3) [back to overview]Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
NCT02087085 (3) [back to overview]Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
NCT02087085 (3) [back to overview]Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
NCT02147691 (20) [back to overview]IGA
NCT02147691 (20) [back to overview]IGA
NCT02147691 (20) [back to overview]Investigator Global Assessment (IGA) at Baseline
NCT02147691 (20) [back to overview]Lesion Count
NCT02147691 (20) [back to overview]Lesion Counts
NCT02147691 (20) [back to overview]Lesion Counts
NCT02147691 (20) [back to overview]Lesion Counts
NCT02147691 (20) [back to overview]VAS
NCT02147691 (20) [back to overview]VAS
NCT02147691 (20) [back to overview]Visual Analog Scale (VAS)
NCT02147691 (20) [back to overview]Clinician's Erythema Assessment
NCT02147691 (20) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02147691 (20) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02147691 (20) [back to overview]DLQI
NCT02147691 (20) [back to overview]DLQI
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema Visual Analog Scale (VAS) Assessment (Subject)
NCT02147691 (20) [back to overview]IGA
NCT02249065 (5) [back to overview]Facial Redness Visual Analog Scale (VAS)
NCT02249065 (5) [back to overview]Subject Facial Redness Questionnaire
NCT02249065 (5) [back to overview]Inflammatory Lesions
NCT02249065 (5) [back to overview]Subject Treatment Satisfaction Questionnaire
NCT02249065 (5) [back to overview]Pre-Treatment Clinician Erythema Assessment (CEA)
NCT02289352 (2) [back to overview]Primary: Percentage of Treatment Success on Day 7
NCT02289352 (2) [back to overview]Percentage of Patients With a Clinical Response of Treatment Success on Day 1
NCT02339584 (1) [back to overview]Mean Diurnal IOP Change From Baseline at Month 3
NCT02385240 (3) [back to overview]Proportion of Subjects With Composite Success
NCT02385240 (3) [back to overview]Proportion of Subjects With Composite Success
NCT02385240 (3) [back to overview]Proportion of Subjects With Composite Success
NCT02419508 (7) [back to overview]Mean Percentage Change From Baseline in IOP at 11:00 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 at 09:00 at Week 6
NCT02419508 (7) [back to overview]Mean Diurnal IOP 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
NCT02419508 (7) [back to overview]Mean Change From Baseline in IOP at 09:00 at Week 6
NCT02616250 (1) [back to overview]Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
NCT02730871 (5) [back to overview]Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
NCT02730871 (5) [back to overview]Mean Diurnal IOP at Week 6
NCT02730871 (5) [back to overview]Mean Percentage Change From Baseline in Diurnal IOP at Week 6
NCT02730871 (5) [back to overview]Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
NCT02730871 (5) [back to overview]Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
NCT02770248 (4) [back to overview]Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
NCT02770248 (4) [back to overview]Least Squares Mean Change From Baseline in Daytime IOP at Week 4
NCT02770248 (4) [back to overview]Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
NCT02770248 (4) [back to overview]Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
NCT02975557 (1) [back to overview]Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.
NCT03048058 (6) [back to overview]Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
NCT03048058 (6) [back to overview]Clinician Erythema Assessment Scale
NCT03048058 (6) [back to overview]Lesion Count
NCT03048058 (6) [back to overview]Patient Severity Assessment (PSA)
NCT03048058 (6) [back to overview]Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)
NCT03048058 (6) [back to overview]Quality of Life With Rosacea
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
NCT03257813 (8) [back to overview]Number of Eyes With Tearing
NCT03257813 (8) [back to overview]Intraocular Pressure (IOP)
NCT03257813 (8) [back to overview]Visual Acuity (VA)
NCT03257813 (8) [back to overview]Number of Eyes With Foreign Body Sensation
NCT03257813 (8) [back to overview]Eye Burning
NCT03257813 (8) [back to overview]Conjunctival Hyperemia
NCT03257813 (8) [back to overview]Chemosis
NCT03257813 (8) [back to overview]Adverse Events
NCT03323164 (6) [back to overview]Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography
NCT03323164 (6) [back to overview]Changes in Flow Index in Treatment Groups Assessed by OCT Angiography
NCT03323164 (6) [back to overview]Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography
NCT03323164 (6) [back to overview]Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography
NCT03323164 (6) [back to overview]Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography
NCT03323164 (6) [back to overview]Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography
NCT03418727 (1) [back to overview]Tolerance of Test Substance Visual Analogue Scale (VAS) Score
NCT03450629 (1) [back to overview]Change From Baseline in Mean Intraocular Pressure
NCT03591874 (3) [back to overview]Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
NCT03591874 (3) [back to overview]Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
NCT03591874 (3) [back to overview]Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores
NCT03760185 (2) [back to overview]Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
NCT03760185 (2) [back to overview]Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study
NCT03782701 (4) [back to overview]Eye Redness
NCT03782701 (4) [back to overview]Intraocular Pressure
NCT03782701 (4) [back to overview]Palpebral Fissure Height
NCT03782701 (4) [back to overview]Eye Discomfort
NCT03785340 (4) [back to overview]Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
NCT03785340 (4) [back to overview]Change From Baseline to 2 Weeks (Day 14) in SANDE Score
NCT03785340 (4) [back to overview]Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
NCT03785340 (4) [back to overview]Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
NCT03966365 (7) [back to overview]Number of Adverse Events
NCT03966365 (7) [back to overview]Participants With Chemosis
NCT03966365 (7) [back to overview]Visual Ability
NCT03966365 (7) [back to overview]Number of Eyes With Epithelial Defects by Grade
NCT03966365 (7) [back to overview]Participants With Conjunctival Hyperemia (CH) by Grade
NCT03966365 (7) [back to overview]Changes in Intraocular Pressure
NCT03966365 (7) [back to overview]Eye Comfort Index

Intraocular Pressure (IOP) for a 24-Hour Period at Week 4

IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. (NCT00457795)
Timeframe: Week 4

InterventionMillimeters of mercury (mmHg) (Mean)
Diurnal IOP Sitting at Week 4Diurnal IOP Supine at Week 4Nocturnal IOP Supine at Week 4
Brimonidine 0.1%16.821.123.0

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Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4

Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. (NCT00457795)
Timeframe: Week 4

InterventionMillimeters of mercury (mmHg) (Mean)
Diurnal OPP Sitting at Week 4Diurnal OPP Supine at Week 4Nocturnal OPP Supine at Week 4
Brimonidine 0.1%46.853.849.2

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Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4

Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. (NCT00457795)
Timeframe: Week 4

InterventionMillimeters of mercury (mmHg) (Mean)
Diurnal Change in OPP Sitting at Week 4Diurnal Change in OPP Supine at Week 4Nocturnal Change in OPP Supine at Week 4
Brimonidine 0.1%1.10.3-3.0

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Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4

Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement. (NCT00457795)
Timeframe: Baseline, Week 4

InterventionMillimeters of mercury (mmHg) (Mean)
Diurnal IOP Sitting at BaselineDiurnal IOP Supine at BaselineNocturnal IOP Supine at BaselineDiurnal IOP Sitting Change from Baseline at Week 4Diurnal IOP Supine Change from Baseline at Week 4Nocturnal IOP Supine Change from Baseline at Wk 4
Brimonidine 0.1%19.223.122.7-2.4-1.90.3

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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. (NCT00658619)
Timeframe: Baseline, 24 Months

,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at 24 Months
200 µg Brimonidine Tartrate Implant Stage 252.1-3.2
400 µg Brimonidine Tartrate Implant Stage 254.8-5.0
Sham (no Implant) Stage 253.7-3.3

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Change From Baseline in Contrast Sensitivity in the Study Eye

Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. (NCT00658619)
Timeframe: Baseline, 24 Months

,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at 24 Months
200 µg Brimonidine Tartrate Implant Stage 222.11.1
400 µg Brimonidine Tartrate Implant Stage 223.7-0.9
Sham (no Implant) Stage 221.70.6

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Change From Baseline in Reading Speed in the Study Eye

Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening. (NCT00658619)
Timeframe: Baseline, 24 Months

,,
InterventionWords per Minute (wpm) (Mean)
BaselineChange from Baseline at 24 Months
200 µg Brimonidine Tartrate Implant Stage 29.62-0.28
400 µg Brimonidine Tartrate Implant Stage 210.21-1.15
Sham (no Implant) Stage 28.720.45

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Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye

Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). (NCT00658619)
Timeframe: Baseline, Month 12

,,
InterventionDisc Area (Mean)
BaselineChange from Baseline at Month 12
200 µg Brimonidine Tartrate Implant Stage 26.8971.006
400 µg Brimonidine Tartrate Implant Stage 26.2190.898
Sham (no Implant) Stage 25.5261.239

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Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye

Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). (NCT00658619)
Timeframe: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24

,,
InterventionDisc Area (Mean)
BaselineChange from Baseline at Month 3Change from Baseline at Month 6Change from Baseline at Month 9Change from Baseline at Month 18Change from Baseline at Month 24
200 µg Brimonidine Tartrate Implant Stage 26.8970.1170.5700.7981.4131.991
400 µg Brimonidine Tartrate Implant Stage 26.2190.1820.4820.6411.3061.744
Sham (no Implant) Stage 25.5260.3990.6090.8571.6972.178

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Change From Baseline in Contrast Sensitivity in the Study Eye

Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. (NCT00661479)
Timeframe: Baseline, Month 6

,,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at Month 6
100 µg Brimonidine Tartrate Implant Group A3.0-2.0
100 µg Brimonidine Tartrate Implant Group B22.34.3
200 µg Brimonidine Tartrate Implant Group B18.0-0.3
400 µg Brimonidine Tartrate Implant Group B15.50.8

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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. (NCT00661479)
Timeframe: Baseline, Month 6

,,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at Month 6
100 µg Brimonidine Tartrate Implant Group A4.00.3
100 µg Brimonidine Tartrate Implant Group B52.73.3
200 µg Brimonidine Tartrate Implant Group B51.0-1.3
400 µg Brimonidine Tartrate Implant Group B48.53.2

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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. (NCT00693485)
Timeframe: Baseline, Month 6

,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at Month 6
200 ug Brimonidine Implant80.6-2.2
400 ug Brimonidine Implant76.02.8
Sham (no Implant)77.30.3

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Percentage of Patients With a Visual Field Improvement in the Study Eye

Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported. (NCT00693485)
Timeframe: Baseline, Month 6

InterventionPercentage of Patients (Number)
400 ug Brimonidine Implant12.0
200 ug Brimonidine Implant9.5
Sham (no Implant)4.2

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Tmax - Time to Maximum Plasma Concentration

time to maximum plasma concentration (NCT00697541)
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose

InterventionHours (Mean)
Treatment A - COL-118 Facial Gel + Saline DropsNA
Treatment B - Vehicle Gel + Brimonidine DropsNA

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Cmax - Maximum Systemic Concentration of Brimonidine

Maximum observed plasma concentration (NCT00697541)
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose

Interventionpg/mL (Mean)
Treatment A - COL-118 Facial Gel + Saline DropsNA
Treatment B - Vehicle Gel + Brimonidine DropsNA

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AUC - Area Under the Curve of Brimonidine

"Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method~After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value.~Thus, no PK analysis could be performed for 0.18% COL-118 facial gel.~After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated." (NCT00697541)
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose

Interventionpg*hr/mL (Mean)
Treatment A - COL-118 Gel + Saline DropsNA
Treatment B - Vehicle Gel + Brimonidine DropsNA

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Mean Intraocular Pressure (IOP) at 8 AM at Week 12

Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye. (NCT00735449)
Timeframe: Week 12

InterventionMillimeters of mercury (mmHg) (Mean)
Combigan®17.0
Timolol Maleate 0.5%17.7

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Mean Intraocular Pressure (IOP) at 10 AM at Week 12

Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. (NCT00735449)
Timeframe: Week 12

InterventionMillimeters of mercury (mmHg) (Mean)
Combigan®15.1
Timolol Maleate 0.5%16.9

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Mean Intraocular Pressure (IOP) at 10 AM at Week 6

Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. (NCT00735449)
Timeframe: Week 6

InterventionMillimeters of mercury (mmHg) (Mean)
Combigan®15.9
Timolol Maleate 0.5%16.7

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Mean Intraocular Pressure (IOP) at 8 AM at Week 6

Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. (NCT00735449)
Timeframe: Week 6

InterventionMillimeters of mercury (mmHg) (Mean)
Combigan®17.3
Timolol Maleate 0.5%17.8

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Number of Subjects With Adverse Events

Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). (NCT00735449)
Timeframe: Week 12

InterventionParticipants (Number)
Combigan®15
Timolol Maleate 0.5%13

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Mean Change From Baseline in Diastolic Blood Pressure at Week 6

Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionmmHg (millimeters of mercury) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-3.3-3.5-1.5-0.5-1.4-1.5-0.5
COMBIGAN0.6-4.3-0.9-2.1-7.3-3.8-0.7

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Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6

End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
Interventioncm/s (centimeters per second) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-0.0-0.60.50.4-0.8-0.1-0.2
COMBIGAN-0.8-1.20.2-0.8-1.4-0.6-0.5

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Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6

Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionArbitrary Units (Mean)
9:00 am1:00 pm5:00 pm9:00 pm
AZARGA-272.4-12.1-26.714.0
COMBIGAN-43.5248.9-51.3-33.2

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Mean Change From Baseline in Systolic Blood Pressure at Week 6

Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionmmHg (millimeters of mercury) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-4.2-2.6-2.9-1.4-2.9-2.9-0.1
COMBIGAN4.5-1.9-0.4-0.6-12.2-3.03.0

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Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks

Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
Interventioncm/s (centimeters per second) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-0.010.020.010.01-0.010.010.01
COMBIGAN-0.010.020.010.010.020.030.03

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Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6

Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
Interventioncm/s (centimeters per second) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-0.00-0.010.000.000.020.01-0.02
COMBIGAN0.010.01-0.000.02-0.010.010.02

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Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6

Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
Interventioncm/s (centimeters per second) (Median)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-1.0-0.72.22.2-2.30.2-0.6
COMBIGAN-3.8-1.41.3-1.4-3.10.01.5

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Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6

Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
Interventioncm/s (centimeters per second) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA0.9-0.21.00.91.90.20.2
COMBIGAN0.70.30.6-0.5-0.5-1.10.9

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Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6

Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

InterventionmmHg (millimeters of mercury) (Mean)
AZARGA2.6
COMBIGAN0.8

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Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6

Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionmmHg (millimeters of mercury) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA2.83.04.44.50.80.32.0
COMBIGAN6.52.13.92.0-5.6-4.00.9

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

Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionmmHg (millimeters of mercury) (Mean)
9:00 am1:00 pm5:00 pm9:00 pm12:00 am3:00 am6:00 am
AZARGA-6.3-6.0-5.6-4.3-1.9-1.3-2.3
COMBIGAN-6.5-6.5-5.2-4.9-1.6-0.6-1.2

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Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6

Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. (NCT00800540)
Timeframe: Week 0, Week 6 (period-based)

,
InterventionArbitrary Units (Mean)
9:00 am1:00 pm5:00 pm9:00 pm
AZARGA15.9-40.7-38.7182.3
COMBIGAN-70.0-89.2-69.1-91.0

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Intraocular Pressure (IOP) at Week 12

Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye. (NCT00811564)
Timeframe: Week 12

InterventionMillimeters of mercury (mm Hg) (Mean)
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate17.75
Latanoprost 0.005% Ophthalmic Solution17.90

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Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®8.86
Cosopt®8.81

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Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®8.61
Cosopt®8.02

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Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®8.52
Cosopt®8.84

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Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®2.63
Cosopt®2.61

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Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®24.5
Cosopt®22.09

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Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®2.73
Cosopt®2.75

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Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®5.83
Cosopt®5.18

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Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats). (NCT00811850)
Timeframe: 1 Month

InterventionCentimeters per second (cm/s) (Mean)
Combigan®2.73
Cosopt®2.87

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Presence of Retinal Vascular Dysregulation (RVD)

We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks. (NCT00824824)
Timeframe: 6 weeks post treatment

InterventionParticipants (Number)
Dorzolamide-Timolol7
Brimonidine-Timolol4

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Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma

intraocular pressure comparison between groups after the Ahmed valve implantation (NCT00869141)
Timeframe: 3 weeks after surgery

InterventionmmHg at postop 3-week (Mean)
Research Arm15.6
Standard of Care Arm20.6

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Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase

intraocular pressure of eyes with hypertensive phase versus without hypertensive phase (NCT00869141)
Timeframe: 1 year after surgery

InterventionmmHg in 1 year postop (Mean)
Hypertensive Phase Group15.1
Non-hypertensive Phase Group11.4

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Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma

Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week (NCT00869141)
Timeframe: within 6 months after surgery

Interventionparticipants (Number)
Research Arm9
Standard of Care Arm12

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Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim

The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim. (NCT00961649)
Timeframe: Baseline, Week 6

,
Interventionmillimeters mercury (mmHg) (Least Squares Mean)
Change from Baseline (BL) at 8 AMChange from BL at +2 hours relative to 8 AM dosingChange from BL at +7 hours relative to 8 AM dosingChange from BL at +9 hours relative to 8 AM dosing
Brinz/Brim-5.5-8.4-5.0-6.3
Brinz+Brim-5.7-8.3-4.4-6.3

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Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim

The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim). (NCT00961649)
Timeframe: Baseline, Week 6

,,
Interventionmillimeters mercury (mmHg) (Least Squares Mean)
Change from Baseline (BL) at 8 AMChange from BL at +2 hours relative to 8 AM dosingChange from BL at +7 hours relative to 8 AM dosingChange from BL at +9 hours relative to 8 AM dosing
Brim-4.1-5.3-3.0-5.9
Brinz-5.7-4.7-2.8-3.9
Brinz/Brim-5.5-8.5-5.4-6.8

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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. (NCT00972374)
Timeframe: Baseline, Month 3

,,
InterventionNumber of Letters Read Correctly (Mean)
BaselineChange from Baseline at Month 3
200 ug Brimonidine Implant53.33.1
400 ug Brimonidine Implant46.66.0
Sham (no Implant)50.34.8

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Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

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 indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported. (NCT00972374)
Timeframe: Month 3

InterventionPercentage of Patients (Number)
400 ug Brimonidine Implant6.7
200 ug Brimonidine Implant6.7
Sham (no Implant)0

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Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit

IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented. (NCT00972374)
Timeframe: 12 Months

InterventionPercentage of Patients (Number)
400 ug Brimonidine Implant20.0
200 ug Brimonidine Implant26.7
Sham (no Implant)28.6

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Intraocular Pressure (IOP)

the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury. (NCT01062971)
Timeframe: basal (day 1 ) and final (day 60)

,
InterventionmmHg (Mean)
baselineFinal
A (Triple Therapy)24.113.9
B (Doble Therapy)23.616.9

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Number of Adverse Events

the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event. (NCT01062971)
Timeframe: basal (day 1 ) and security call (day 75)

Interventionevents (Number)
A (Triple Therapy)2
B (Doble Therapy)6

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Presence of Retinal Blood Flow Autoregulation

We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%. (NCT01105065)
Timeframe: 8 weeks

Interventionparticipants (Number)
Patients With RVD14

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Frequency Doubling Perimetry

Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant. (NCT01105065)
Timeframe: 8 weeks

InterventiondB (Mean)
RVD Patients Pre-brimonidine Treatment-2.03
RVD Patients Post-brimonidine Treatment-2.77

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Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP)

The episcleral venous pressure was measured using the episcleral venomanometer (NCT01144494)
Timeframe: 6 weeks plus 2 days

,
InterventionmmHg (Mean)
Daytime SeatedNighttime Supine
Artificial Tears10.311.2
Intraocular Pressure Lowering Drug10.311.3

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Outflow Facility

Calculated from the measurement taken during the day and night. Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants. (NCT01144494)
Timeframe: 6 weeks

InterventionμL/min (Mean)
IOP Lowering Drug (Day)0.28
IOP Lowering Drug (Night)0.28
Artificial Tears (Day)0.29
Artificial Tears (Night)0.29

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Uveoscleral Outflow

Calculated from the modified Goldmann equation using data obtained at 9 am and 11 am. Goldmann equation involves data from aqueous flow, tonography/outflow facility, episcleral venous pressure and IOP. Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants. (NCT01144494)
Timeframe: 6 weeks

InterventionμL/min (Mean)
IOP Lowering Drug0.84
Artificial Tears0.72

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Aqueous Flow

Measured by fluorophotometry during the day and night on 29 participants. (NCT01144494)
Timeframe: 6 weeks

,
Interventionµl/min (Mean)
day-time measurementnight-time measurement
Artificial Tears2.31.5
IOP Lowering Drug2.41.5

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Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm

Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm. (NCT01144494)
Timeframe: 6 weeks

,
InterventionmmHg (Mean)
Seated day-time 9 amSeated day-time 11 amSupine day-time 9 amSupine day-time 11 amSeated night-time 9 pmSeated night-time 11 pm
Artificial Tears20.319.925.424.718.018.4
Intraocular Pressure Lowering Drug18.118.023.123.116.016.7

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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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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 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 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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Highest Aqueous Humor Level of Brimonidine in the Study Eye

The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens. (NCT01229410)
Timeframe: 60 Days

InterventionNanogram/milliliter (ng/mL) (Number)
400 µg Brimonidine Tartrate Implant17.5
200 µg Brimonidine Tartrate Implant12.5

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Highest Vitreous Humor Level of Brimonidine in the Study Eye

The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye. (NCT01229410)
Timeframe: 60 Days

InterventionNanogram/milliliter (ng/mL) (Number)
400 µg Brimonidine Tartrate Implant137.0
200 µg Brimonidine Tartrate Implant34.9

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Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)

Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood. (NCT01229410)
Timeframe: 60 Days

InterventionPercentage of Patient Samples (Number)
400 µg Brimonidine Tartrate Implant53.3
200 µg Brimonidine Tartrate Implant72.6

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Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4

Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). (NCT01229462)
Timeframe: Baseline, Week 4

,
Interventionmm Hg (Mean)
BaselineChange from baseline at Week 4
Alphagan® and Timolol Concurrent24.53-5.70
Combigan®25.07-6.21

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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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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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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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Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade

To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade. (NCT01255306)
Timeframe: 6 months

,,
Interventionmicrometer (Mean)
RNFL thickness at 7th postop. dayRNFL thickness at 30th postop. dayRNFL thickness at 90th postop. dayRNFL thickness at 180th postop. day
CONTROL87.0787.9387.3788.93
NO IOP96.0893.7696.44101.76
RAISED IOP96.3497.9198.4499.34

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Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography

Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade. (NCT01255306)
Timeframe: 6 months

,
Interventionmicrometer (Mean)
RNFL thickness at 7th postop. dayRNFL thickness at 30th postop. dayRNFL thickness at 90th postop. dayRNFL thickness at 180th postop. day
CONTROL EYES87.0787.9387.3788.93
STUDY EYES96.2396.0997.56100.40

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Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)

At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01297517)
Timeframe: Month 3

,,
Interventionmillimeters mercury (mm Hg) (Least Squares Mean)
8 am (before study drug instillation)+2 hrs relative to 8 am dosing+7 hrs relative to 8 am dosing+9 hrs relative to 8 am dosing
Brimonidine23.319.721.318.8
Brinzolamide21.620.420.420.0
Brinzolamide/Brimonidine20.517.218.717.0

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Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3

The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01297920)
Timeframe: Month 3

,,
Interventionmillimeters mercury (mm HG) (Least Squares Mean)
8 AM (before study drug instillation)+ 2 hours relative to 8 AM dosing+ 7 hours relative to 8 AM dosing+ 9 hours relative to 8 AM dosing
Brimonidine23.219.921.518.9
Brinz/Brim21.118.019.517.2
Brinzolamide22.020.820.720.4

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Mean Diurnal IOP Change From Baseline at Month 3

Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01309204)
Timeframe: Baseline (Day 1), Month 3

Interventionmillimeters of mercury (mmHg) (Least Squares Mean)
Brinz/Brim-8.5
Brinz+Brim-8.3

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Mean Diurnal IOP Change From Baseline at Month 3

Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01310777)
Timeframe: Baseline (Day 1), Month 3

Interventionmillimeters of mercury (mmHg) (Least Squares Mean)
Brinz/Brim-7.9
Brinz-6.5
Brim-6.4

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Mean Ocular Discomfort Score

Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). (NCT01426867)
Timeframe: Week 1

InterventionUnits on a scale (Mean)
Brinz/Brim0.8
Brinzolamide0.4
Brimonidine0.3

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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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Composite Success

Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period (NCT01659853)
Timeframe: Hour 6 on Day 15

Interventionpercentage of subjects (Number)
CD07805/47 Gel 0.5% and Vehicle14.3
Azelaic Acid Gel 15%5.7

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Onset of Action

Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application (NCT01659853)
Timeframe: 30 minutes after baseline treatment application on Day 15

Interventionpercentage of subjects (Number)
CD07805/47 Gel 0.5 and Vehicle31.4
Azelaic Acid 15%29.4

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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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EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8

EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement. (NCT01885000)
Timeframe: Day 8

,
InterventionPercentage of participants (Number)
1. I have no problems in walking about1.I have some problems in walking about2. I have no problems with self-care2. I have some problems washing or dressing myself3.I have no problems with performing usual activity3.I have some problems with performing usual activity4.I have no pain or discomfort4.I have moderate pain or discomfort4.I have extreme pain or discomfort5.I am not anxious or depressed5.I am moderately anxious or depressed5.I am extremely anxious or depressed
Brimonidine Tartrate 0.5% Gel95.74.397.82.291.38.758.741.3087.010.92.2
Vehicle92.97.197.62.490.59.576.221.42.473.826.20

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Percentage of Participants With Facial Redness Questionnaire at Day 8

Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life. (NCT01885000)
Timeframe: Day 8

,
Interventionpercentage of participants (Number)
1. Very dissatisfied/ Dissatisfied1. Dissatisfied or Satisfied/Satisfied2. Very unacceptable/Unacceptable2.Acceptable or Unacceptable/Acceptable3.Not at all/Slightly3. Somewhat /Moderately /Extremely4. Not at all4. Slightly/ Somewhat/Moderately/Extremely5.Not at all/Slightly/ Somewhat5. Moderately/Extremely6. Not at all6.Slightly/Somewhat/Moderately/Extremel y7. Not at all7. Slightly/Somewhat/Moderately/Extremely8.Not at all8. Slightly/Somewhat9. Not at all/Rarely9.Some of the time/Often/Constantly10.Not at all/Rarely10. Some of the time/Often/Constantly11. Not at all11.Slightly/Somewhat/Moderately/Extremely12.Not at all12.Slight/Somewhat/Moderate/Extreme/ Not Applicable/I'm not working
Brimonidine Tartrate 0.5% Gel45.754.347.952.128.271.728.371.773.426.723.976.18.791.260.923.947.852.247.852.234.865.226.773.4
Vehicle69.031.059.540.521.478.69.590.447.652.331.768.214.385.861.911.948.851.247.652.421.478.523.876.2

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Change From Baseline in Facial Inflammatory Lesion Counts at Day 8

Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator. (NCT01885000)
Timeframe: Day 8

Interventionnumber of lesions (Mean)
Brimonidine Tartrate 0.5% Gel0.3
Vehicle0.4

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Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8

EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement. (NCT01885000)
Timeframe: Day 8

InterventionScore on scale (Mean)
Brimonidine Tartrate 0.5% Gel76.0
Vehicle80.2

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Number of Participants Reported Adverse Events

All clinical medical events, whether observed by the investigator or reported by the participant and whether or not thought to be product- or study procedure-related were considered as adverse events. (NCT01885000)
Timeframe: From start of study drug administration up to Day 8

InterventionParticipants (Count of Participants)
Brimonidine Tartrate 0.5% Gel15
Vehicle9

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Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment

Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported. (NCT01885000)
Timeframe: Day 8

InterventionPercentage of participants (Number)
Brimonidine Tartrate 0.5% Gel69.6
Vehicle40.4

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Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8

DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on participant's life, [Grade 2-5]: Small effect at all on participant's life, [Grade 6-10]: Moderate effect at all on participant's life, [Grade 11-20]: Very large effect at all on participant's life, [Grade 21-30]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater. (NCT01885000)
Timeframe: Baseline, Day 8

Interventionpercent change (Mean)
Brimonidine Tartrate 0.5% Gel-15.4
Vehicle-32.6

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Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)

Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1- Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. Percentage of participants with at least two grade improvement in the CEA was reported. (NCT01885000)
Timeframe: Day 8

InterventionPercentage of participants (Number)
Brimonidine Tartrate 0.5% Gel47.8
Vehicle7.1

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Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment

Percentage of participants with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness. (NCT01885000)
Timeframe: Day 8

InterventionPercentage of participants (Number)
Brimonidine Tartrate 0.5% Gel41.3
Vehicle23.8

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Mean Diurnal Intraocular Pressure (IOP) at Week 6

Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01937299)
Timeframe: Week 6

InterventionmmHg (Mean)
SIMBRINZA17.44
Vehicle20.34

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Mean Diurnal IOP Change From Baseline to Week 6

Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. (NCT01937299)
Timeframe: Baseline, Week 6

InterventionmmHg (Mean)
SIMBRINZA-5.10
Vehicle-2.22

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Mean Diurnal IOP Percentage Change From Baseline to Week 6

Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. (NCT01937299)
Timeframe: Baseline, Week 6

Interventionpercent change (Mean)
SIMBRINZA-22.27
Vehicle-9.57

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Mean Diurnal Intraocular Pressure (IOP) at Week 6

Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01937312)
Timeframe: Week 6

InterventionmmHg (Mean)
SIMBRINZA17.01
Vehicle20.37

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Mean Diurnal IOP Change From Baseline to Week 6

Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. (NCT01937312)
Timeframe: Baseline, Week 6

InterventionmmHg (Mean)
SIMBRINZA-5.69
Vehicle-1.99

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Mean Diurnal IOP Percentage Change From Baseline to Week 6

Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. (NCT01937312)
Timeframe: Baseline, Week 6

Interventionpercent change (Mean)
SIMBRINZA-24.88
Vehicle-8.50

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Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)

IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01937312)
Timeframe: Week 6

,
InterventionmmHg (Mean)
8 AM10 AM3 PM5 PM
SIMBRINZA19.415.817.215.6
Vehicle21.420.219.919.9

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Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale

Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness. (NCT01959230)
Timeframe: 0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 15 and 29

,
Interventionunits on a scale (Mean)
Predose on Day 1Change from Predose at 1 min Postdose on Day 1Change from Predose at 360 min Postdose on Day 1Change from Predose at 480 min Postdose on Day 1Predose on Day 15Change from Predose at 1 min Postdose on Day 15Change from Predose at 5 min Postdose on Day 15Predose on Day 29Change from Predose at 1 min Postdose on Day 29Change from Predose at 5 min Postdose on Day 29
Brimonidine Tartrate1.82-1.06-0.78-0.631.57-0.78-1.031.64-0.88-1.21
Brimonidine Tartrate Vehicle1.71-0.23-0.10-0.131.24-0.16-0.251.36-0.24-0.37

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Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale

Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness. (NCT01959230)
Timeframe: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1

,
Interventionunits on a scale (Mean)
Predose5 minutes Postdose15 minutes Postdose30 minutes Postdose60 minutes Postdose90 minutes Postdose120 minutes Postdose180 minutes Postdose240 minutes Postdose
Brimonidine Tartrate1.820.580.580.590.610.600.630.730.82
Brimonidine Tartrate Vehicle1.711.401.351.401.401.451.531.541.54

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Ocular Redness as Measured by the Participant

Ocular redness was scored daily pre-dose and post-dose on Days 1 to 29 and scored daily on Days 30 to 36 by the participant using a 0 to 4 unit scale (not allowing half unit increments). A lower score was indicative of less redness. The LOCF method used for this Secondary Outcome Measure was for imputing missing daily post-dose mean scores for entire days. If ≥1 score was provided for a day, imputation was not done. Imputation was done within the dosing period and separately within the follow-up period. The average (mean) daily pre-dose and post-dose scores for the dosing period Day 1 to Day 15 and dosing period Day 15 to Day 29, and the average (mean) daily score for the follow-up period Day 29 to Day 36 are reported. (NCT01959230)
Timeframe: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36

,
Interventionunits on a scale (Mean)
Daily Predose Score of Day 1 to Day 15Daily Postdose Score of Day 1 to Day 15Daily Predose Score of Day 15 to Day 29Daily Postdose Score of Day 15 to Day 29Daily Score of Day 29 to Day 36
Brimonidine Tartrate1.520.851.450.801.69
Brimonidine Tartrate Vehicle1.831.851.591.631.69

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Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29

An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma. (NCT01959243)
Timeframe: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29

,
InterventionParticipants (Count of Participants)
Predose Installation on Day 1Postdose Installation on Day 1Postdose Installation on Day 8Postdose Installation on Day 15Postdose Installation on Day 29
Brimonidine Tartrate337336326326323
Brimonidine Tartrate Vehicle170169167166164

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section. (NCT01959243)
Timeframe: Baseline up to Day 29

,
InterventionParticipants (Count of Participants)
Participants with at Least 1 TEAEParticipants with at Least 1 Ocular TEAEParticipants with at least 1 Non-Ocular TEAEParticipants with at least 1 Serious TEAEParticipants Discontinued from Study due to TEAEs
Brimonidine Tartrate66442325
Brimonidine Tartrate Vehicle38251602

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Drop Comfort Assessment as Assessed by the Participant

"Drop comfort assessment (0-10 unit scale in which a score of 0 denotes very comfortable and 10 is very uncomfortable) was performed by the participant. Participant's average score across eyes at each time point were used for analysis." (NCT01959243)
Timeframe: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1

,
Interventionunits on a scale (Mean)
Upon Dose Installation30 Seconds Postdose Installation1 Minute Postdose Installation
Brimonidine Tartrate0.40.40.4
Brimonidine Tartrate Vehicle0.40.30.4

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Mean 24-hour IOP at Week 4

24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01978600)
Timeframe: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

,
InterventionmmHg (Mean)
Baseline (Day 0)Week 4
Simbrinza23.617.9
Timolol22.818.2

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Mean Diurnal IOP at Week 4

Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01978600)
Timeframe: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM

,
InterventionmmHg (Mean)
Baseline (Day 0)Week 4
Simbrinza23.217.3
Timolol22.217.7

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Mean Nocturnal IOP at Week 4

Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). (NCT01978600)
Timeframe: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

,
InterventionmmHg (Mean)
Baseline (Day 0)Week 4
Simbrinza24.218.6
Timolol23.618.9

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Percentage of Participants Reporting 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. (NCT01987752)
Timeframe: Up to 2.6 Years

InterventionPercentage of participants (Number)
Combigan® Ophthalmic Solution6.56

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Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported. (NCT01987752)
Timeframe: Baseline, Week 4

InterventionPercentage of participants (Number)
Combigan® Ophthalmic Solution85.69

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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). (NCT02003534)
Timeframe: Baseline, Month 3

InterventionMillimeters of Mercury (mmHg) (Mean)
BaselineChange from Baseline at Month 3 (N=330)
0.15% Brimonidine Tartrate25.4-6.3

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Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24

BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis. (NCT02087085)
Timeframe: Baseline (Day 1) to Month 24

Interventionletters read correctly (Least Squares Mean)
400 µg Brimonidine Implant-10.9
Sham-9.7

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Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24

Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis. (NCT02087085)
Timeframe: Baseline (Day 1) to Month 24

Interventionletters read correctly (Least Squares Mean)
400 µg Brimonidine Implant-8.1
Sham-6.7

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Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24

GA lesion area was measured in mm^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis. (NCT02087085)
Timeframe: Baseline (Day 1) to Month 24

Interventionmm^2 (Least Squares Mean)
400 µg Brimonidine Implant3.1455
Sham3.5044

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.8
Brimonidine 0.33% Gel1.8

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.6
Brimonidine 0.33% Gel1.8

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Investigator Global Assessment (IGA) at Baseline

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3
Brimonidine 0.33% Gel3.1

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Lesion Count

(NCT02147691)
Timeframe: Week 4

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.1
Brimonidine 0.33% Gel2.1

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Lesion Counts

(NCT02147691)
Timeframe: Week 12

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel0.7
Brimonidine 0.33% Gel1.2

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Lesion Counts

(NCT02147691)
Timeframe: Week 8

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.0
Brimonidine 0.33% Gel1.7

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Lesion Counts

The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line (NCT02147691)
Timeframe: Baseline

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3.3
Brimonidine 0.33% Gel4.5

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VAS

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3.8
Brimonidine 0.33% Gel4.0

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VAS

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel4.4
Brimonidine 0.33% Gel4.5

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Visual Analog Scale (VAS)

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel4.5
Brimonidine 0.33% Gel5.2

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Clinician's Erythema Assessment

Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured. (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel2.3
Brimonidine 0.33% Gel2.1

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Dermatology Life Quality Index (DLQI)

The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible. (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel2.6
Brimonidine 0.33% Gel2.9

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Dermatology Life Quality Index (DLQI)

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.8
Brimonidine 0.33% Gel2.6

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DLQI

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.2
Brimonidine 0.33% Gel2.8

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DLQI

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel2.6

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.2

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.6
Brimonidine 0.33% Gel1.3

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.4

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Erythema Visual Analog Scale (VAS) Assessment (Subject)

Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable) (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel5.5
Brimonidine 0.33% Gel5.6

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.4

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Facial Redness Visual Analog Scale (VAS)

The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS (NCT02249065)
Timeframe: 14 days (Day 1 (Baseline), Day 14/Exit)

InterventionParticipants (Count of Participants)
Day 172074134Day 1472074134
NoneVery MildMildModerateSevereVery Severe
Mirvaso Gel1
Mirvaso Gel31
Mirvaso Gel57
Mirvaso Gel48
Mirvaso Gel38
Mirvaso Gel63
Mirvaso Gel45
Mirvaso Gel44
Mirvaso Gel22
Mirvaso Gel6

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Subject Facial Redness Questionnaire

Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions) (NCT02249065)
Timeframe: 14 days (Day 1 (Baseline) and Day 14/Exit)

InterventionParticipants (Mean)
Not Bothered (Mean [SD], Day 1, Baseline)Bothered (Mean [SD], Day 1, Baseline)Missing (Day 1, Baseline)Not Bothered (Mean [SD], Day 14)Bothered (Mean [SD], Day 14)Missing (Day 14)
Mirvaso Gel75.3104.71112.667.31.1

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Inflammatory Lesions

Change from baseline in facial inflammatory lesion count (NCT02249065)
Timeframe: 14 days (Day 1 (Baseline) and Day 14/Exit)

Interventionlesions (Mean)
Day 1: LesionsDay 14: LesionsDay 14: Change From Baseline
Mirvaso Gel.61.51

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Subject Treatment Satisfaction Questionnaire

Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions) (NCT02249065)
Timeframe: 14 days (Day 14/Exit)

InterventionParticipants (Mean)
Satisfied Participants (Mean [SD])Dissatisfied Participants (Mean [SD])Missing
Mirvaso Gel127.352.71.0

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Pre-Treatment Clinician Erythema Assessment (CEA)

The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application. (NCT02249065)
Timeframe: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)

InterventionParticipants (Count of Participants)
Day 1 (Baseline)72074134Day 772074134Day 1472074134
MissingClear SkinAlmost ClearMild ErythemaModerate ErythemaSevere Erythema
Mirvaso Gel7
Mirvaso Gel144
Mirvaso Gel30
Mirvaso Gel0
Mirvaso Gel3
Mirvaso Gel18
Mirvaso Gel84
Mirvaso Gel24
Mirvaso Gel13
Mirvaso Gel4
Mirvaso Gel25
Mirvaso Gel39
Mirvaso Gel86
Mirvaso Gel27

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Primary: Percentage of Treatment Success on Day 7

Percentage of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1). (NCT02289352)
Timeframe: 7 days

Interventionpercentage of participants (Number)
Test: Brimonidine 0.33% Gel9.95
Reference: Mirvaso 0.33% Gel10.36
Placebo0

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Percentage of Patients With a Clinical Response of Treatment Success on Day 1

(NCT02289352)
Timeframe: 1 day

Interventionpercentage of participants (Number)
Test: Brimonidine 0.33% Gel30.89
Reference: Mirvaso 0.33% Gel30.89
Placebo8.62

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Mean Diurnal IOP Change From Baseline at Month 3

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis. (NCT02339584)
Timeframe: Baseline (Day 0), Month 3

InterventionmmHg (Mean)
Brinz/Brim-7.2
Brinz+Brim-7.3

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Proportion of Subjects With Composite Success

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales (NCT02385240)
Timeframe: Day 15 at hour 3

InterventionParticipants (Count of Participants)
Test Product61
Reference Product58
Placebo Gel19

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Proportion of Subjects With Composite Success

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales (NCT02385240)
Timeframe: Day 15 at hour 6

InterventionParticipants (Count of Participants)
Test Product60
Reference Product58
Placebo Gel23

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Proportion of Subjects With Composite Success

2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales (NCT02385240)
Timeframe: Day 15 at hour 9

InterventionParticipants (Count of Participants)
Test Product53
Reference Product42
Placebo Gel18

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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 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 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 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 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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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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Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):

Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1) (NCT02616250)
Timeframe: week 12/Hour 3

InterventionParticipants (Count of Participants)
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream53
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream35

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

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. (NCT02730871)
Timeframe: Baseline, Week 6

InterventionmmHg (Mean)
Simbrinza + Duotrav-4.5
Vehicle + Duotrav-2.4

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Mean Diurnal IOP at Week 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). 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 used for the analyses. (NCT02730871)
Timeframe: Week 6

InterventionmmHg (Mean)
Simbrinza + Duotrav17.1
Vehicle + Duotrav19.4

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Mean Percentage Change From Baseline in Diurnal IOP at Week 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. (NCT02730871)
Timeframe: Baseline, Week 6

Interventionpercentage change (Mean)
Simbrinza + Duotrav-20.7
Vehicle + Duotrav-11.1

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Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. (NCT02730871)
Timeframe: Baseline, Week 6

,
Interventionpercentage change (Mean)
Percent change at 9:00 HrPercent change at 11:00 Hr
Simbrinza + Duotrav-20.2-25.0
Vehicle + Duotrav-14.1-11.7

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Mean Change From Baseline in IOP (09:00, 11:00) at Week 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. (NCT02730871)
Timeframe: Baseline, Week 6

,
InterventionmmHg (Mean)
Baseline 9:00 HrBaseline 11:00 HrChange from Baseline 9:00 HrChange from Baseline 11:00 Hr
Simbrinza + Duotrav22.221.4-4.4-5.4
Vehicle + Duotrav22.521.4-3.2-2.5

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Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4

IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. (NCT02770248)
Timeframe: Baseline (Day 0), Week 4

InterventionmmHg (Least Squares Mean)
SIMBRINZA-3.09
Vehicle-0.60

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Least Squares Mean Change From Baseline in Daytime IOP at Week 4

IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. (NCT02770248)
Timeframe: Baseline (Day 0), Week 4

InterventionmmHg (Least Squares Mean)
SIMBRINZA-3.93
Vehicle-0.51

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Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4

IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. (NCT02770248)
Timeframe: Baseline (Day 0), Week 4

InterventionmmHg (Least Squares Mean)
SIMBRINZA-1.88
Vehicle-0.73

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Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4

IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. (NCT02770248)
Timeframe: Baseline (Day 0), Week 4

,
InterventionmmHg (Least Squares Mean)
8AM10AM12PM2PM4PM6PM8PM10PM12AM2AM4AM6AM
SIMBRINZA-3.28-5.05-4.03-3.36-3.95-4.46-3.42-2.10-1.79-2.30-1.42-1.95
Vehicle-0.49-0.61-0.27-0.66-0.51-0.32-0.72-0.67-0.83-0.55-0.98-0.63

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Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.

"Subjects assessed their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end and marks at an equal distance starting from 0 mm and leading up to 100 mm (0 10 20 30 40 50 60 70 80 90 100). The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), week 3, week 6, week 9 and week 12. Subjects will place a single slash mark across the horizontal line between the end labeled completely intolerable (0 mm) and easily tolerable (100mm)." (NCT02975557)
Timeframe: 12 weeks

,,
InterventionParticipants (Count of Participants)
Tolerability (100%)Tolerability (95%)Tolerability (90%)
Brimonidine 0.075%101
Brimonidine 0.15%300
Placebo411

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Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)

To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject (NCT03048058)
Timeframe: 6 months

Interventionpercentage of medication use (Median)
Brimonidine Topical Gel 0.33% & Survey8.2
Brimonidine Topical Gel 0.33% & SOC6.9

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Clinician Erythema Assessment Scale

Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome. (NCT03048058)
Timeframe: baseline and 6 months

,
Interventionunits on a scale (Mean)
Baseline6 Months
Brimonidine Topical Gel 0.33% & SOC2.52.3
Brimonidine Topical Gel 0.33% & Survey2.42.7

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Lesion Count

Change in total Lesion count (NCT03048058)
Timeframe: Baseline and 6 months

,
Interventioncount of lesions (Mean)
Baseline6 Months
Brimonidine Topical Gel 0.33% & SOC10.46.2
Brimonidine Topical Gel 0.33% & Survey42.7

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Patient Severity Assessment (PSA)

Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes. (NCT03048058)
Timeframe: baseline and 6 months

,
Interventionunits on a scale (Mean)
Baseline6 Months
Brimonidine Topical Gel 0.33% & SOC2.41.17
Brimonidine Topical Gel 0.33% & Survey1.61.14

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Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)

Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes. (NCT03048058)
Timeframe: baseline and 6 months

,
Interventionunits on a scale (Mean)
Baseline6 Months
Brimonidine Topical Gel 0.33% & SOC6.21.5
Brimonidine Topical Gel 0.33% & Survey2.41.43

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Quality of Life With Rosacea

Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes. (NCT03048058)
Timeframe: baseline and 6 months

,
Interventionunits on a scale (Mean)
Baseline6 Months
Brimonidine Topical Gel 0.33% & SOC13.713
Brimonidine Topical Gel 0.33% & Survey17.515.57

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Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 3 hours

,,
InterventionmmHg (Mean)
Baseline3 hours
Artificial Tears15.219.5
Brimonidine 0.2%15.714.7
Brinzolamide/Brimonidine FC15.612.7

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Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 24 hours

,,
InterventionmmHg (Mean)
Baseline24 hours
Artificial Tears15.215.8
Brimonidine 0.2%15.715.5
Brinzolamide/Brimonidine FC15.614.6

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Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 1 week

,,
InterventionmmHg (Mean)
Baseline1 week
Artificial Tears15.215.6
Brimonidine 0.2%15.715.3
Brinzolamide/Brimonidine FC15.615.5

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Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 1 hour

,,
InterventionmmHg (Mean)
Baseline1 hour
Artificial Tears15.219.5
Brimonidine 0.2%15.714.7
Brinzolamide/Brimonidine FC15.613.7

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Number of Eyes With Tearing

Tearing will be evaluated by the presence or absence of it and the number of affected by group will be reported (NCT03257813)
Timeframe: Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventioneyes (Number)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A987
Sequence B299

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Intraocular Pressure (IOP)

"Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg.~The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60)." (NCT03257813)
Timeframe: Change from Baseline intraocular pressure at day 30 and 60.

,
InterventionmmHg (Mean)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A13.6013.1912.60
Sequence B12.1311.8011.24

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Visual Acuity (VA)

"The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing normal acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.~Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated." (NCT03257813)
Timeframe: Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventionscore on a scale (Mean)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A38.3136.8538.98
Sequence B39.4840.4335.50

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Number of Eyes With Foreign Body Sensation

Foreign body sensation will be evaluated by the presence or absence of it and the number of affected by group will be reported. (NCT03257813)
Timeframe: Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventioneyes (Number)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A14145
Sequence B14167

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Eye Burning

Eye ocular burning will be evaluated by the presence or absence of it and the number of affected by group will be reported. (NCT03257813)
Timeframe: Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventionnumber of eye burning (Number)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A161214
Sequence B181819

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Conjunctival Hyperemia

the conjunctival hyperemia will be evaluated by the presence or absence of it and the percentage of affected by group will be reported. (NCT03257813)
Timeframe: Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventionpercentage of eyes (Number)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A39.637.520.8
Sequence B11.125.913.0

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Chemosis

Chemosis: qualitative ordinal variable, will be evaluated by the presence or absence of it and the percentage of affected by group will be reported. (NCT03257813)
Timeframe: Baseline (day 1) crossover visit (day 30) and final visit (day 60)

,
Interventionpercentage of chemosis (Number)
basal visit (day 1)Crossover visit (day 30)Final visit (day 60)
Sequence A000
Sequence B3.73.70

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Adverse Events

The presence of adverse events by percentage between groups will be evaluated. the scale is present or absent. (NCT03257813)
Timeframe: 75 days, includes the security call

,
Interventionpercentage of adverse events (Number)
mildmoderatesevere
Krytantek Ofteno18.272.79.1
PRO-12255.644.40

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Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography

Comparison of the percent change in Optic Nerve Head Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,,,
Interventionpercent change (Mean)
OverallPOAGNTGOHTN
Brimonidine-5.24-13.73-4.170.55
Control B2.6912.400.32-2.68
Control T1.96-2.386.211.21
Timolol-0.69-1.652.47-3.52

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Changes in Flow Index in Treatment Groups Assessed by OCT Angiography

Percent change in peripapillary Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,
Interventionpercent change (Mean)
Overall groupPOAGNTGOHTN
Brimonidine Group-5.23-12.55-4.871.71
Timolol Group0.330.692.76-2.92

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Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography

Percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,
Interventionpercent change (Mean)
Overall groupPOAGNTGOHTN
Brimonidine Group-0.51-0.96-0.04-0.58
Timolol Group2.590.964.122.37

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Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography

Comparison of the percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,,,
Interventionpercent change (Mean)
Overall groupPOAGNTGOHTN
Brimonidine-0.51-1.62-0.04-0.58
Control B1.702.892.020.44
Control T-2.05-2.8-3.420.34
Timolol2.590.964.122.37

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Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography

Comparison of the percent change in peripapillary flow index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,,,
Interventionpercent change (Mean)
Overall groupPOAGNTGOHTN
Brimonidine-5.23-14.91-4.871.71
Control B2.3512.810.22-3.89
Control T1.61-3.657.57-0.26
Timolol0.330.692.76-2.92

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Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography

Comparison of the percent change in optic nerve head vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure. (NCT03323164)
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

,,,
InterventionPercent change (Mean)
OverallPOAGNTGOHTN
Brimonidine1.08-1.002.441.65
Control B1.272.222.13-0.34
Control T0.32-2.681.701.67
Timolol0.912.650.160.08

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Tolerance of Test Substance Visual Analogue Scale (VAS) Score

"Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled completely intolerable (0 mm) and easily tolerable (100mm)." (NCT03418727)
Timeframe: Days 1, 28, 56, and 84

,,
Interventionscore on a scale (Mean)
Day 1Day 28Day 56Day 84
Brimonidine and Corticosteroid Combination Therapy82.191.192.087.8
Brimonidine Monotherapy87.087.485.685.9
Placebo95.088.291.094.8

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Change From Baseline in Mean Intraocular Pressure

(NCT03450629)
Timeframe: Week 12 8 AM, 10 AM and 4 PM

,
InterventionmmHg (Mean)
8 AM +/- 30 min10 AM +/- 30 min4 PM +/- 30 min
Brimonidine Tartrate Ophthalmic Solution20.7918.3117.57
PDP-71620.3517.3817.99

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Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score

The VBR consists of a set of ten images illustrating different degrees of ocular redness, ranging from normal to severe, and each image is assigned a value from 10 (least redness) to 100 (most redness). The bulbar conjunctival injection of the participant's eye (nasal and temporal) was examined via slit-lamp examination and compared to the reference images in the VBR and graded accordingly. (NCT03591874)
Timeframe: Baseline, Day 84

,
Interventionscore on a scale (Mean)
BaselineDay 84Change from Baseline to Day 84
OCU-30052.2334.88-17.62
Placebo51.9237.71-13.96

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Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score

"Participants were asked to rate their worst ocular pain/discomfort in the preceding 24 hours using a 10-point scale ranging from None (score=0) to Unbearable/Excruciating (score=10)." (NCT03591874)
Timeframe: Baseline, Day 84

,
Interventionscore on a scale (Mean)
BaselineDay 84Change from Baseline to Day 84
OCU-3006.24.8-1.8
Placebo6.54.1-2.6

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Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores

"The SANDE questionnaire is a short VAS assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from rarely to all of the time, and the symptom severity from very mild to very severe. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100, with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms." (NCT03591874)
Timeframe: Baseline, Day 84

,
Interventionscore on a scale (Mean)
BaselineDay 84Change from Baseline to Day 84
OCU-30074.450.5-26.5
Placebo69.144.1-26.6

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Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye

The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye (NCT03760185)
Timeframe: 45 minutes post dilation after 7 days of treatment

Interventionmillimeters (Mean)
Brimonidine Tartrate 0.2%6.76
Control - Untreated7.17

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Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study

Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study (NCT03760185)
Timeframe: 45 minutes post dilation after 7 days of treatment

Interventionmillimeters (Mean)
Brimonidine Tartrate 0.2%0.39
Control - Untreated0.91

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Eye Redness

Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe). (NCT03782701)
Timeframe: Baseline, 5, 15 and 30 minutes after application

,
InterventionParticipants (Count of Participants)
Baseline - NoneBaseline - MildBaseline - ModerateBaseline - Severe5 minutes after application - None5 minutes after application - Mild5 minutes after application - Moderate5 minutes after application - Severe15 minutes after application - None15 minutes after application - Mild15 minutes after application - Moderate15 minutes after application - Severe30 minutes after application - None30 minutes after application - Mild30 minutes after application - Moderate30 minutes after application - Severe
Lumify Eye Drop241720384104021041110
Saline Solution Eye Drop251620619171182410261700

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Intraocular Pressure

Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer (NCT03782701)
Timeframe: Baseline, 5, 15 and 30 minutes after application

,
InterventionmmHg (Mean)
Baseline30 minutes after applciation
Lumify Eye Drop16.5415.54
Saline Solution Eye Drop16.7015.58

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Palpebral Fissure Height

Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs. (NCT03782701)
Timeframe: Baseline, 5, 15 and 30 minutes after application

,
Interventionmilimeter (Mean)
Baseline5 minutes after application15 minutes after application30 minutes after application
Lumify Eye Drop9.649.929.859.86
Saline Solution Eye Drop9.669.969.969.84

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Eye Discomfort

Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe). (NCT03782701)
Timeframe: Baseline, 5, 15 and 30 minutes after application

,
InterventionParticipants (Count of Participants)
Baseline - NoneBaseline - MildBaseline - ModerateBaseline - Severe5 minutes after application - none5 minutes after application - mild5 minutes after application - moderate5 minutes after application - severe15 minutes after application - none15 minutes after application - mild15 minutes after application - moderate15 minutes after application - severe30 minutes after application - none30 minutes after application - mild30 minutes after application - moderate30 minutes after application - severe
Lumify Eye Drop43000403004111039400
Saline Solution Eye Drop43000384014021040300

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Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores

Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. (NCT03785340)
Timeframe: Baseline, 2 Weeks (Day 14)

,
Interventionscore on a scale (Mean)
Baseline2 Weeks (Day 14)Change from Baseline at 2 Weeks (Day 14)
OCU-3104.23.8-0.4
Placebo4.13.4-0.7

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Change From Baseline to 2 Weeks (Day 14) in SANDE Score

"The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from rarely to all of the time, and the symptom severity from very mild to very severe. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms." (NCT03785340)
Timeframe: Baseline, 2 weeks (Day 14)

,
Interventionscore on a scale (Mean)
Baseline2 weeks (Day 14)Change from Baseline at 2 weeks (Day 14)
OCU-31073.061.3-11.6
Placebo72.758.6-14.1

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Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores

Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome. (NCT03785340)
Timeframe: Baseline, 4 Weeks (Day 28)

,
Interventionscore on a scale (Mean)
Baseline4 Weeks (Day 28)Change from Baseline at 4 Weeks (Day 28)
OCU-3104.23.6-0.6
Placebo4.13.2-0.9

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Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score

"The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from rarely to all of the time, and the symptom severity from very mild to very severe. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms." (NCT03785340)
Timeframe: Baseline, 4 weeks (Day 28)

,
InterventionScore on a scale (Mean)
Baseline4 weeks (Day 28)Change from Baseline at 4 weeks (Day 28)
OCU-31073.056.6-16.4
Placebo72.757.2-15.5

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Number of Adverse Events

primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group. (NCT03966365)
Timeframe: during the 14 days of evaluation, including the safety call (day 14)

Interventionadverse events (Number)
PRO-12228
Krytantek Ofteno®31

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Participants With Chemosis

The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

InterventionParticipants (Count of Participants)
PRO-1220
Krytantek Ofteno®0

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Visual Ability

"The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 or 1.0 in decimal and the worst 20/200 or 0.1 in decimal number.~For the appropriate management of the data, the result of the fraction obtained from the snellen scale is transformed to decimals, in this case subjects close to or equal to 1.0 have better visual acuity while subjects close to or equal to 0.1 have worse visual acuity.~The decimal equivalence scale is the result of the division of the fraction obtained in the Snellen chart. where 20/20 = 1.0; Do not confuse with Logmar scale where 20/20 = 0.0~Equivalences Snellen Scale = decimals: 20/200=0.1, 20/100=0.2, 20/50=0.4, 20/40=0.5, 20/30=0.66, 20/25=0.8, 20/20=1.0, etc." (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

InterventionDecimal score (Mean)
PRO-1220.949
Krytantek Ofteno®0.907

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Number of Eyes With Epithelial Defects by Grade

The epithelial defects will be evaluated by means of two stains, green lissamine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

,
Interventioneyes (Number)
Green lissamine grade 0Green lissamine grade 1Green lissamine grade 2Green lissamine grade 3Green lissamine grade 4Fluorescein grade 0Fluorescein grade 1Fluorescein grade 2Fluorescein grade 3Fluorescein grade 4
Krytantek Ofteno®164400222000
PRO-122202000220000

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Participants With Conjunctival Hyperemia (CH) by Grade

Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological. (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

,
InterventionParticipants (Count of Participants)
Normal (0)Very mild (1)Mild (2)Moderate (3)Severe (4)
Krytantek Ofteno®93000
PRO-122100100

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Changes in Intraocular Pressure

the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

InterventionmmHg (Mean)
PRO-12212.32
Krytantek Ofteno®11.78

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Eye Comfort Index

"It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.~Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort." (NCT03966365)
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)

Interventionunits on a scale (Mean)
PRO-12224.6
Krytantek Ofteno®27.0

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