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olopatadine hydrochloride

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Description

Olopatadine Hydrochloride: An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5282402
CHEBI ID31933
SCHEMBL ID23213
MeSH IDM0325753

Synonyms (113)

Synonym
kw-4679
alo-4943a
patanase
olopatadine hydrochloride
pataday
o-ppds
allelock
dibenz(b,e)oxepin-2-acetic acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, hydrochloride, (z)-
kw 4679
11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid, hydrochloride
dibenz(b,e)oxepin-2-acetic acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, hydrochloride, (z)-
11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid hydrochloride
alo4943a
MLS001401465
olopatadine hcl
smr000469220
allelock (tn)
140462-76-6
D01192
olopatadine hydrochloride (jp17/usp)
patanol (tn)
O0361 ,
kw4679
olopatadine (as hydrochloride)
A807652
(z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic acid hydrochloride
dtxsid0046486 ,
tox21_112242
dtxcid8026486
cas-140462-76-6
CCG-101141
olopatadine hydrochloride [usan:usp]
alo 4943a
olopine
unii-2xg66w44kf
patadine
2xg66w44kf ,
de 114
olopax
pazeo
BCP9001022
olopatadine hydrochloride [who-dd]
ryaltris component olopatadine hydrochloride
olopatadine hydrochloride [jan]
olopatadine hydrochloride [usan]
olopatadine hydrochloride [mi]
olopatadine hydrochloride [usp monograph]
olopatadine hydrochloride [orange book]
olopatadine hydrochloride [usp-rs]
olopatadine hydrochloride component of ryaltris
olopatadine hydrochloride [mart.]
olopatadine hydrochloride [ema epar]
olopatadine hydrochloride [vandf]
AKOS015895232
S2494
olopatadine (hydrochloride)
HY-B0426A
NC00391
SCHEMBL23213
tox21_112242_1
NCGC00263532-01
KS-1228
HVRLZEKDTUEKQH-NOILCQHBSA-N
Q-201511
AKOS025149118
(z)-11-[3-(dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic acid hydrochloride
mfcd00875716
hydrochloride, olopatadine
EX-A1347
olopatadine hydrochlorde
SR-01000763388-4
olopatadine hydrochloride, united states pharmacopeia (usp) reference standard
C72607
olopatadine hydrochloride, >=98% (hplc)
CHEBI:31933
alo4943a;kw4679
olopatadine hydrochloride (opatanol)
dibenz[b,e]oxepin-2-acetic acid, 11-[3-(dimethylamino)propylidene]-6,11-dihydro-, hydrochloride (1:1), (11z)-
Q27255766
(z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)aceticacidhydrochloride
olopatadine hydrochloride- bio-x
BO164171
2-[(2z)-2-[3-(dimethylamino)propylidene]-9-oxatricyclo[9.4.0.0,3,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-5-yl]acetic acid hydrochloride
EN300-25953569
al4943a
2-{2-[3-(dimethylamino)propylidene]-9-oxatricyclo[9.4.0.0,3,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-5-yl}acetic acid hydrochloride
EN300-19652056
Z2568665949
1010110-90-3
cvs eye allergy itch relief
once daily relief
olopatadine hydrochloride ophthalmic solutiontwice daily
olopatadine hydrochloride ophthalmic
olopatadine hydrochloride ophthalmic solutiononce daily relief
pataday twice a day relief
olopatadine hydrochloride nasal
(11-((1z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenzo(b,e)oxepin-2-yl)acetic acid monohydrochloride
olopatadine hydrochloride ophthalmic solution
cvs eye allergy itch relieftwice daily
eye allergy itch and redness relief
eye allergy itch and redness relieftwice daily relief
pataday once daily relief
olopatadine hydrochloride (usp monograph)
clear eyes once daily eye allergy itch relief
pataday twice daily relief
cvs eye allergy itch reliefonce daily
olopatadine hydrochloride (mart.)
olopatadine hydrochloride (usp-rs)
olopatadine hydrochloride ophthalmic solutiononce daily
olopatadine hydrochloride usp, 0.1%
eye allergy itch reliefonce daily relief
olopatadine hydrochloride (usan:usp)
eye allergy itch relief

Research Excerpts

Overview

Olopatadine hydrochloride is an antihistamine and mast cell stabilizer available as oral, intranasal and ocular preparations. It is an H1-receptor-blocker but has other anti-allergic pharmacological potencies.

ExcerptReferenceRelevance
"Olopatadine hydrochloride is an antihistamine and mast cell stabilizer available as oral, intranasal and ocular preparations. "( Olopatadine hydrochloride ophthalmic solution for the treatment of allergic conjunctivitis.
Dimov, V; Eidelman, F; Gonzalez-Estrada, A; Reddy, K, 2017
)
3.34
"Olopatadine hydrochloride (olopatadine) is an antiallergic agent with histamine H(1) receptor antagonistic action."( Efficacy of repeated pretreatment with olopatadine hydrochloride on rhinitis induced by intranasal instillation of toluene-2,4-diisocyanate in rats.
Kimoto, N; Tamura, T, 2009
)
1.34
"Olopatadine hydrochloride is an antihistamine and mast cell stabilizer available in three forms, including oral, intranasal and ocular preparations. "( Pharmacokinetic evaluation of olopatadine for the treatment of allergic rhinitis and conjunctivitis.
Dimov, V; Nickels, AS; Wolf, R, 2011
)
1.81
"Olopatadine hydrochloride is an H1-receptor-blocker but has other anti-allergic pharmacological potencies. "( Anti-allergic drug olopatadine suppresses murine contact hypersensitivity and downmodulates antigen-presenting ability of epidermal Langerhans cells.
Ito, T; Kobayashi, M; Matsubara, A; Takahashi, H; Takigawa, M; Tokura, Y, 2003
)
1.76
"Olopatadine hydrochloride (olopatadine) is an anti-allergic drug that functions as a histamine H(1) antagonist and inhibits both mast cell degranulation and the release of arachidonic acid metabolites in various types of cells. "( Differential regulation of IL-4 expression and degranulation by anti-allergic olopatadine in rat basophilic leukemia (RBL-2H3) cells.
Hasegawa, K; Karasawa, A; Masaki, S; Matsubara, M; Ohmori, K, 2004
)
1.77
"Olopatadine hydrochloride (Olopatadine) is an antiallergic drug with selective histamine H(1) receptor antagonist activity."( Effect of an antiallergic drug (Olopatadine hydrochloride) on TARC/CCL17 and MDC/CCL22 production by PBMCs from patients with atopic dermatitis.
Furukawa, H; Kaneko, F; Nakamura, K; Takahashi, M, 2004
)
1.33
"Olopatadine hydrochloride 0.1% is an effective agent for relieving the signs and symptoms of vernal keratoconjunctivitis. "( Efficiency of olopatadine hydrochloride 0.1% in the treatment of vernal keratoconjunctivitis and goblet cell density.
Bilgin, LK; Corum, I; Ilhan, R; Yeniad, B, 2005
)
2.13
"Olopatadine hydrochloride (olopatadine) is an antiallergic drug with histamine H(1) receptor antagonistic activity. "( Olopatadine suppresses the migration of THP-1 monocytes induced by S100A12 protein.
Hasegawa, K; Kaneko, S; Kishimoto, K; Ohmori, K; Tamura, T, 2006
)
1.78
"Olopatadine hydrochloride (olopatadine) is an antiallergic agent with histamine H(1) receptor antagonistic action. "( Olopatadine ameliorates rat experimental cutaneous inflammation by improving skin barrier function.
Amano, T; Chida, M; Matsubara, M; Tamura, T, 2008
)
1.79
"Olopatadine hydrochloride (olopatadine) is an anti-allergic agent with histamine H1 receptor antagonistic action."( Effect of olopatadine hydrochloride, an anti-histamine drug, on rhinitis induced by intranasal instillation of toluene-2,4-diisocyanate in rats.
Komai, M; Tamura, T, 2008
)
1.47

Toxicity

ExcerptReferenceRelevance
" Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults."( Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.
Amar, NJ; Brubaker, MJ; Drake, M; Hampel, FC; Marple, BF; Mohar, D; Ratner, PH; Roland, PS; Silver, LH; Turner, D; van Bavel, JH; Wall, GM, 2005
)
0.64
" Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults."( Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.
Barnes, JR; Berger, WE; Bernstein, DI; Brubaker, MJ; Dimas, C; Finn, AF; Hampel, FC; Larsen, LV; Marple, BF; Meltzer, EO; Potts, SL; Ratner, PH; Roland, PS; Silver, LH; Wall, GM, 2005
)
0.64
" Safety parameters assessed included adverse events, visual acuity, ocular signs (slit-lamp assessments), dilated fundus examinations, intraocular pressure (IOP), pulse, and blood pressure."( Safety and tolerability of olopatadine 0.2% in children and adolescents.
Edwards, MR; Gross, RD; Lichtenstein, SJ; Pasquine, TA; Robertson, SM; Wells, DT, 2007
)
0.34
" All adverse events reported were mild or moderate."( Safety and tolerability of olopatadine 0.2% in children and adolescents.
Edwards, MR; Gross, RD; Lichtenstein, SJ; Pasquine, TA; Robertson, SM; Wells, DT, 2007
)
0.34
"2% administered once-daily for 6 weeks is safe and well tolerated in children and adolescent patients."( Safety and tolerability of olopatadine 0.2% in children and adolescents.
Edwards, MR; Gross, RD; Lichtenstein, SJ; Pasquine, TA; Robertson, SM; Wells, DT, 2007
)
0.34
" Adverse events were nonserious and infrequent in all treatment groups."( Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis.
Drake, M; Fairchild, CJ; Meltzer, EO; Roland, PS; Wall, GM; Wells, D,
)
0.13
"When antiallergic agents are used to treat allergic conjunctivitis other than olopatadine, a particularly toxic effect on conjunctival cells associated with azelastine and ketotifen, rather than olopatadine, should be considered clinically."( Comparison of the conjunctival toxicity of topical ocular antiallergic agents.
Kim, N; Lee, JE; Lee, JS; Oum, BS, 2008
)
0.35
" In both studies, subjects were evaluated based on physical/nasal examinations and adverse events (AEs)."( Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis.
Berger, WE; Casale, TB; Meltzer, EO; Ratner, PH; Wall, GM,
)
0.44
" Adverse events occurred in 33."( Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.
Kaneko, K; Magara, H; Okubo, K; Okuda, M, 2010
)
1.8
"Olopatadine hydrochloride 5 mg twice daily is an effective and safe treatment for perennial allergic rhinitis in children."( Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.
Kaneko, K; Magara, H; Okubo, K; Okuda, M, 2010
)
3.25
" There were no serious adverse events."( [A 10-week safety and efficacy evaluation of olopatadine, 0.2% instilled twice-daily in patients with allergic conjunctivitis in Japan].
Ando, M; Ohno, S, 2012
)
0.38
" Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety."( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety.
Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013
)
0.39
" Adverse event profiles were comparable with sedation being the commonest complaint."( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety.
Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013
)
0.39
"Olopatadine is a safe and more effective alternative to levocetirizine in the treatment of CU."( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety.
Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013
)
0.39
" Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs)."( Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis.
Amar, NJ; Berman, G; Caracta, CF; Gross, GN; Tantry, SK, 2019
)
0.51
" Average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs) were also assessed."( Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis.
Andrews, CP; Mohar, D; Salhi, Y; Tantry, SK, 2020
)
0.56
"All three topical ophthalmic medications used in the study are safe and effective in the treatment of allergic conjunctivitis."( Comparative analysis of safety and efficacy of Alcaftadine 0.25%, Olopatadine hydrochloride 0.2% and Bepotastine besilate 1.5% in allergic conjunctivitis.
Ayyappanavar, S; Gangasagara, SB; Jayanthi, CR; Kumar, K; Mittal, P; Preethi, B; Rathod, BLS; Sridhar, S, 2021
)
0.86
" Average morning and evening 12-h reflective total nasal symptom score (rTNSS), instantaneous total nasal symptom score (iTNSS), reflective total ocular symptom score (rTOSS), instantaneous total ocular symptom score(iTOSS), Physician-assessed nasal symptom score (PNSS), rhinoconjunctivitis quality of life (RQLQ), rhinitis control assessment test (RCAT) and adverse events (AEs) were measured."( Efficacy and safety of twice-daily olopatadine-mometasone combination nasal spray (GSP301) in the treatment of allergic rhinitis: a systematic review and meta-analysis.
Chen, R; Sima, G; Zhang, Y; Zheng, D, 2022
)
0.72
"GSP301 is a safe and well-tolerated medication."( Efficacy and safety of twice-daily olopatadine-mometasone combination nasal spray (GSP301) in the treatment of allergic rhinitis: a systematic review and meta-analysis.
Chen, R; Sima, G; Zhang, Y; Zheng, D, 2022
)
0.72
" Additional assessments included instantaneous Total Nasal Symptom Score, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire, reflective Total Ocular Symptoms Score, instantaneous Total Ocular Symptoms Score, individual symptoms, Physician-assessed Nasal Symptom Score, and adverse events."( Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis.
Amar, NJ; Caracta, CF; Hampel, FC; Prenner, BM; Wu, W, 2022
)
0.72
" Treatment-emergent adverse events occurred in 12."( Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis.
Amar, NJ; Caracta, CF; Hampel, FC; Prenner, BM; Wu, W, 2022
)
0.72

Pharmacokinetics

ExcerptReferenceRelevance
" In the multiple-dose trial, all pharmacokinetic parameters examined, except the maximum concentration, showed no difference between the first and the last administration."( Pharmacokinetics of KW-4679 in the elderly: single-dose and multiple-dose trials.
Kobayashi, H; Kobayashi, S; Nakamura, T; Shigeyama, C; Tateishi, T, 1998
)
0.3
"The pharmacokinetic parameters for olopatadine in 12 healthy Chinese subjects (six males and six females) were assessed by determining olopatadine concentrations with a validated liquid chromatography-tandem mass spectrometry method."( Pharmacokinetics of orally administered single- and multiple-dose olopatadine in healthy Chinese subjects: an open-label study.
Chen, WL; Chu, NN; Li, XN; Xu, HR, 2009
)
0.35
"The pharmacokinetic parameters (mean +/- SD) for olopatadine following a single dose were: maximum plasma concentration (C(max)) 69."( Pharmacokinetics of orally administered single- and multiple-dose olopatadine in healthy Chinese subjects: an open-label study.
Chen, WL; Chu, NN; Li, XN; Xu, HR, 2009
)
0.35
" To assess the relative bioavailability of olopatadine in the fixed-dose nasal spray versus two monotherapies, pharmacokinetic (PK) estimates, maximum plasma concentration (Cmax), area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance."( Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
" To evaluate the relative bioavailability of mometasone, pharmacokinetic (PK) estimates, the maximum plasma concentration (Cmax), the area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance."( Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
" A slightly higher Cmax was observed with GSP301 than with MF, but AUC was comparable."( Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
" Blood samples were collected at predetermined time points for pharmacokinetic analyses of the drug in plasma."( Pharmacokinetics and pharmacodynamics of olopatadine following administration via nasogastric tube to healthy horses.
Fukuda, K; Kasashima, Y; Kuroda, T; Kusano, K; Mita, H; Mizobe, F; Nagata, SI; Takizawa, Y; Tamura, N, 2019
)
0.51

Compound-Compound Interactions

ExcerptReferenceRelevance
"To determine whether Patanol in combination with the systemic antihistamine Claritin (loratadine, Schering, Kenilworth, NJ) reduces the ocular itching associated with allergic conjunctivitis more effectively than Claritin alone."( The added benefit of local Patanol therapy when combined with systemic Claritin for the inhibition of ocular itching in the conjunctival antigen challenge model.
Abelson, MB; Lanier, RQ, 1999
)
0.3

Bioavailability

ExcerptReferenceRelevance
"To assess the relative bioavailability of olopatadine administered as GSP301 versus two olopatadine monotherapy nasal spray formulations."( Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
" To assess the relative bioavailability of olopatadine in the fixed-dose nasal spray versus two monotherapies, pharmacokinetic (PK) estimates, maximum plasma concentration (Cmax), area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance."( Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
"Olopatadine bioavailability with GSP301 was comparable with OLO-sponsor and OLO."( Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
"To assess the relative bioavailability of mometasone administered as GSP301 FDC versus two mometasone monotherapy NS formulations."( Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
" To evaluate the relative bioavailability of mometasone, pharmacokinetic (PK) estimates, the maximum plasma concentration (Cmax), the area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance."( Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
"Mometasone bioavailability with GSP301 was comparable with MF-sponsor and MF monotherapies."( Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.
Patel, P; Salapatek, AM; Talluri, RS; Tantry, SK, 2018
)
0.48
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

This paper describes two simple, specific, accurate, and precise methods for estimation of olopatadine hydrochloride (OLO) in tablet dosage form. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship and superiority of OlO over placebo.

ExcerptRelevanceReference
" Subject/objective symptoms improved significantly after administering the agent, and the total dosage of the combined topical steroids was also significantly decreased after administration (p<0."( [Examination of effectiveness of olopatadine hydrochloride in atopic dermatitis].
Mashiko, M; Shimizu, H; Shimizu, T, 2005
)
0.61
" Newer topical medications are being used that have multiple actions, such as an antihistaminic effect coupled with mast-cell stabilisation, and which require reduced daily dosing due to their longer duration of action."( Pharmacotherapy of allergic eye disease.
Flynn, TH; Larkin, F; Manzouri, B; Ono, SJ; Wyse, R, 2006
)
0.33
"2% to vehicle (identical formation without the active ingredient) for dosing on a once-daily schedule."( Safety and tolerability of olopatadine 0.2% in children and adolescents.
Edwards, MR; Gross, RD; Lichtenstein, SJ; Pasquine, TA; Robertson, SM; Wells, DT, 2007
)
0.34
" Allergy symptoms (sneezing, runny, itchy, and stuffy nose) were rated by patients at 16 time points during 12 hours after dosing and patient satisfaction was assessed at 4 and 12 hours postdose."( Onset and duration of action of nasal sprays in seasonal allergic rhinitis patients: olopatadine hydrochloride versus mometasone furoate monohydrate.
Brubaker, M; Conroy, JP; Crenshaw, K; Garadi, R; Kaji, Y; Patel, D; Wall, GM; Whitling, A,
)
0.36
" The effects of various histamine H(1) receptor antagonists on the dose-response curve for histamine were evaluated."( The noncompetitive antagonism of histamine H1 receptors expressed in Chinese hamster ovary cells by olopatadine hydrochloride: its potency and molecular mechanism.
Funahashi, J; Hayashi, K; Matsumoto, Y; Mori, K; Yano, H, 2008
)
0.56
" The added convenience of a once-a-day dosing regimen is a major advancement in this drug class."( Olopatadine 0.2% ophthalmic solution: the first ophthalmic antiallergy agent with once-daily dosing.
Abelson, MB; Gomes, PJ, 2008
)
0.35
"2% ophthalmic solution, fluticasone furoate nasal spray, a tear substitute, or saline nasal spray), dosed with study medication, and challenged 15 minutes later, after which ocular allergic signs and symptoms were assessed."( A comparison of olopatadine 0.2% ophthalmic solution versus fluticasone furoate nasal spray for the treatment of allergic conjunctivitis.
Abelson, MB; Gomes, PJ; Kennedy, K; Mahr, T; Rosenwasser, LJ,
)
0.13
" A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship and superiority of olopatadine hydrochloride over placebo in children aged 7 to 16 years with perennial allergic rhinitis."( Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.
Kaneko, K; Magara, H; Okubo, K; Okuda, M, 2010
)
2
"This paper describes two simple, specific, accurate, and precise methods for estimation of olopatadine hydrochloride (OLO) in tablet dosage form."( Stability-indicating high-performance column liquid chromatography and high-performance thin-layer chromatography methods for the determination of olopatadine hydrochloride in tablet dosage form.
Kumar, AM; Ravi, TK; Varghese, SJ,
)
0.55
" Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (-1."( Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study.
Patel, P; Salapatek, AM; Tantry, SK, 2019
)
0.51
" Multiple standard addition method was applied to enable the determination of OLO which is considered as the weakly absorbing species as well as the minor component in a challenging dosage form ratio (4:1)."( UV spectrophotometric methods for simultaneous determination of ketorolac tromethamine and olopatadine hydrochloride: Application of multiple standard addition for assay of ophthalmic solution.
El-Malla, SF; Hammad, SF; Rady, MM, 2023
)
1.13
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
dibenzooxazepineAn organic heterotricyclic compound consisting of two benzene rings fused to a seven-membered ring containing one oxygen and one nitrogen atom.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
GLI family zinc finger 3Homo sapiens (human)Potency0.26600.000714.592883.7951AID1259369
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency2.68320.000214.376460.0339AID720691
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency18.83220.023723.228263.5986AID743222
gemininHomo sapiens (human)Potency1.77830.004611.374133.4983AID624297
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (46)

Assay IDTitleYearJournalArticle
AID180554The compound was tested in vivo for inhibitory effect on 48-h homologous passive cutaneous anaphylaxis (PCA) in rats administered perorally1992Journal of medicinal chemistry, May-29, Volume: 35, Issue:11
Synthesis and antiallergic activity of 11-(aminoalkylidene)-6,11-dihydrodibenz[b,e]oxepin derivatives.
AID86745Binding affinity for histamine H1 receptor from guinea pig cerebellum, using [3H]pyrilamine as radioligand at 0.1 uM1992Journal of medicinal chemistry, May-29, Volume: 35, Issue:11
Synthesis and antiallergic activity of 11-(aminoalkylidene)-6,11-dihydrodibenz[b,e]oxepin derivatives.
AID77121The compound was tested in vivo for the inhibition of IgG1-mediated bronchoconstriction in guinea pig at 0.03 mg/kg administered perorally1992Journal of medicinal chemistry, May-29, Volume: 35, Issue:11
Synthesis and antiallergic activity of 11-(aminoalkylidene)-6,11-dihydrodibenz[b,e]oxepin derivatives.
AID141584Binding affinity for Muscarinic acetylcholine receptor M1 from rat striatum, using [3H]quinuclidinyl benzilate as radioligand at 10 uM.1992Journal of medicinal chemistry, May-29, Volume: 35, Issue:11
Synthesis and antiallergic activity of 11-(aminoalkylidene)-6,11-dihydrodibenz[b,e]oxepin derivatives.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (281)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's31 (11.03)18.2507
2000's127 (45.20)29.6817
2010's92 (32.74)24.3611
2020's31 (11.03)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 51.91

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

MetricThis Compound (vs All)
Research Demand Index51.91 (24.57)
Research Supply Index6.04 (2.92)
Research Growth Index4.81 (4.65)
Search Engine Demand Index129.87 (26.88)
Search Engine Supply Index3.05 (0.95)

This Compound (51.91)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials103 (32.49%)5.53%
Reviews27 (8.52%)6.00%
Case Studies18 (5.68%)4.05%
Observational1 (0.32%)0.25%
Other168 (53.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (58)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Envir [NCT01287338]Phase 2143 participants (Actual)Interventional2010-10-31Terminated(stopped due to Lack of definitive clinical results.)
[NCT01344083]Phase 260 participants (Anticipated)Interventional2011-04-30Completed
A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7% [NCT01326858]Phase 150 participants (Actual)Interventional2011-04-30Completed
A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mom [NCT03444506]Phase 2180 participants (Actual)Interventional2014-01-27Completed
A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC) [NCT01076439]Phase 40 participants (Actual)InterventionalWithdrawn
[NCT01109485]Phase 442 participants (Actual)Interventional2010-03-31Completed
[NCT01258309]Phase 3129 participants (Actual)Interventional2010-12-31Completed
[NCT01294969]Phase 447 participants (Actual)Interventional2010-09-30Completed
A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen [NCT00836485]Phase 2122 participants (Actual)Interventional2009-02-28Completed
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis [NCT01037179]Phase 3110 participants (Actual)Interventional2010-02-28Completed
Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Pla [NCT06126952]Phase 284 participants (Anticipated)Interventional2023-10-30Recruiting
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis Wit [NCT00562159]Phase 3439 participants (Actual)Interventional2007-11-30Completed
A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis [NCT00655109]Phase 460 participants (Actual)Interventional2008-02-29Completed
Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis [NCT00789555]Phase 41,260 participants (Actual)Interventional2008-11-30Completed
Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen. [NCT01007253]Phase 421 participants (Actual)Interventional2009-11-30Completed
[NCT01159769]Phase 4215 participants (Actual)Interventional2010-06-30Completed
A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis [NCT05265910]Phase 458 participants (Actual)Interventional2021-12-14Completed
Mast-Cell Stabilizing Effects of Olopatadine [NCT00389025]Phase 424 participants (Actual)Interventional2006-10-31Completed
Randomized Controlled Trial Comparing Olopatadine 0.1% Ophthalmic Solution With Hylo-Dual Ophthalmic Preparation in Children With Seasonal Allergic Conjunctivitis [NCT03186755]Phase 442 participants (Anticipated)Interventional2017-06-11Recruiting
A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1% Olopatadine Hydrochloride) Ophthalmic Solution for the Treatment of Allergic Conjunctivi [NCT01119287]Phase 4180 participants (Actual)Interventional2010-03-31Completed
Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride [NCT00489398]Phase 425 participants (Anticipated)Interventional2007-07-31Withdrawn(stopped due to Protocol changes)
A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model [NCT01479374]Phase 3397 participants (Actual)Interventional2012-01-31Completed
[NCT00818805]Phase 450 participants (Actual)Interventional2008-07-31Completed
[NCT01495338]Phase 160 participants (Actual)Interventional2011-12-31Completed
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients [NCT00578929]Phase 32,388 participants (Actual)Interventional2007-09-30Completed
A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in [NCT02631551]Phase 31,180 participants (Actual)Interventional2016-03-31Completed
A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis [NCT01272089]Phase 4300 participants (Actual)Interventional2011-05-31Completed
[NCT00845195]Phase 4150 participants (Actual)Interventional2009-03-31Completed
DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis [NCT04708821]Phase 431 participants (Actual)Interventional2021-04-30Completed
Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis [NCT01657240]Phase 30 participants (Actual)Interventional2014-11-30Withdrawn(stopped due to Formula Reformulation)
[NCT01470118]Phase 4127 participants (Actual)Interventional2011-10-31Completed
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen [NCT02251613]Phase 450 participants (Actual)Interventional2013-12-31Completed
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivi [NCT00550550]Phase 3345 participants (Actual)Interventional2007-11-30Completed
A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects [NCT02322216]Phase 3383 participants (Actual)Interventional2014-12-31Completed
[NCT00979615]Phase 4129 participants (Actual)Interventional2009-09-30Completed
A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects [NCT00987272]Phase 3267 participants (Actual)Interventional2009-10-31Completed
A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monoth [NCT02318303]Phase 21,111 participants (Actual)Interventional2014-12-31Completed
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2% [NCT01697969]Phase 417 participants (Actual)Interventional2012-09-30Completed
A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC) [NCT01435460]Phase 3300 participants (Actual)Interventional2010-08-31Completed
Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID [NCT01450176]30 participants (Actual)Interventional2011-09-30Completed
A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC) [NCT01282138]Phase 413 participants (Actual)Interventional2010-12-31Completed
A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis [NCT00331500]Phase 3287 participants (Actual)Interventional2006-04-18Completed
A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis [NCT05314621]Phase 461 participants (Actual)Interventional2021-12-31Completed
PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS [NCT04776096]Phase 497 participants (Actual)Interventional2021-03-10Completed
[NCT02161146]Phase 3240 participants (Actual)Interventional2014-06-04Completed
Safety Study of Olopatadine Nasal Spray [NCT00578331]Phase 3890 participants (Actual)Interventional2006-12-31Completed
A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial [NCT00691665]Phase 4130 participants (Actual)Interventional2008-05-31Completed
Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model [NCT01743027]Phase 3902 participants (Actual)Interventional2013-01-31Completed
A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis W [NCT01700192]Phase 31,482 participants (Actual)Interventional2013-01-31Completed
A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model [NCT00534794]Phase 479 participants (Actual)Interventional2007-10-31Completed
Expression of Inflammatory Mediators in Allergic Conjunctivitis [NCT00609128]21 participants (Actual)Interventional2000-09-30Completed
[NCT00794144]Phase 2132 participants (Actual)Interventional2008-10-31Completed
[NCT00772304]Phase 4102 participants (Actual)Interventional2008-10-31Completed
Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline [NCT00775658]24 participants (Actual)Interventional2008-01-31Completed
[NCT01732757]Phase 4157 participants (Actual)Interventional2012-11-30Completed
A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without [NCT02478398]Phase 31,025 participants (Actual)Interventional2015-07-20Completed
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily [NCT01698814]Phase 3518 participants (Actual)Interventional2012-10-31Completed
Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study - [NCT01363700]Phase 387 participants (Actual)InterventionalCompleted
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00534794 (2) [back to overview]Change in Ocular Itch Score From Baseline
NCT00534794 (2) [back to overview]Ocular Comfort Score at 12 Hours
NCT00550550 (4) [back to overview]Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS
NCT00550550 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
NCT00550550 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
NCT00550550 (4) [back to overview]Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
NCT00562159 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
NCT00562159 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS
NCT00562159 (4) [back to overview]Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS
NCT00562159 (4) [back to overview]Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
NCT00578331 (2) [back to overview]Average Number of Days of Rescue Medication Taken
NCT00578331 (2) [back to overview]Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
NCT00578929 (2) [back to overview]Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
NCT00578929 (2) [back to overview]Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
NCT00609128 (1) [back to overview]Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion
NCT00691665 (4) [back to overview]Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
NCT00691665 (4) [back to overview]Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
NCT00691665 (4) [back to overview]Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
NCT00691665 (4) [back to overview]Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
NCT00772304 (1) [back to overview]Product Preference Questionnaire for Immediate Taste
NCT00775658 (2) [back to overview]The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
NCT00775658 (2) [back to overview]The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
NCT00789555 (6) [back to overview]Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
NCT00789555 (6) [back to overview]Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
NCT00789555 (6) [back to overview]Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
NCT00789555 (6) [back to overview]Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
NCT00789555 (6) [back to overview]Self-Rated Relief Assessment at Day 30
NCT00789555 (6) [back to overview]Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
NCT00794144 (1) [back to overview]Number of Participants With Anatomic Nasal Exam Abnormalities
NCT00818805 (1) [back to overview]"Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire"
NCT00845195 (4) [back to overview]Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
NCT00845195 (4) [back to overview]Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
NCT00845195 (4) [back to overview]Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
NCT00845195 (4) [back to overview]Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline
NCT00979615 (5) [back to overview]Mean Change Postnasal Drip Reflective Score
NCT00979615 (5) [back to overview]Mean Change Nasal Congestion Reflective Score
NCT00979615 (5) [back to overview]Mean Change in Sneezing Reflective Score
NCT00979615 (5) [back to overview]Mean Change in Rhinorrhea Reflective Score
NCT00979615 (5) [back to overview]Mean Change in 2-week rTNSS From Baseline
NCT01007253 (6) [back to overview]Total Number of Eosinophils
NCT01007253 (6) [back to overview]Total Number of Sneezes
NCT01007253 (6) [back to overview]Total Nasal Symptoms Score Difference
NCT01007253 (6) [back to overview]Total Eye Symptoms Score Difference
NCT01007253 (6) [back to overview]Change in Tryptase Level (Across Nasal Challenges)
NCT01007253 (6) [back to overview]Change in Histamine Level (Across Nasal Challenges)
NCT01119287 (2) [back to overview]Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo
NCT01119287 (2) [back to overview]Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo
NCT01159769 (2) [back to overview]Overall Patient Satisfaction
NCT01159769 (2) [back to overview]Overall Patient Satisfaction
NCT01282138 (2) [back to overview]Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
NCT01282138 (2) [back to overview]Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
NCT01363700 (4) [back to overview]Mean Hyperemia Score Compared to Olopatadine Period2
NCT01363700 (4) [back to overview]Mean Hyperemia Score Compared to Placebo Period1
NCT01363700 (4) [back to overview]Mean Ocular Itching Score Compared to Olopatadine Period2
NCT01363700 (4) [back to overview]Mean Ocular Itching Score Compared to Placebo Period1
NCT01435460 (4) [back to overview]Bulbar Conjunctival Injection
NCT01435460 (4) [back to overview]Ocular Itching
NCT01435460 (4) [back to overview]Ocular Itching
NCT01435460 (4) [back to overview]Bulbar Conjunctival Injection
NCT01470118 (8) [back to overview]Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
NCT01470118 (8) [back to overview]Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
NCT01470118 (8) [back to overview]Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
NCT01479374 (7) [back to overview]Mean Conjunctival Redness at 24 Hours Duration of Action
NCT01479374 (7) [back to overview]Mean Conjunctival Redness at Onset of Action
NCT01479374 (7) [back to overview]Mean Ocular Itching at 16 Hours Duration of Action
NCT01479374 (7) [back to overview]Mean Ocular Itching at 24 Hours Duration of Action
NCT01479374 (7) [back to overview]Mean Ocular Itching at Onset of Action
NCT01479374 (7) [back to overview]Mean Total Redness at 24 Hours Duration of Action
NCT01479374 (7) [back to overview]Mean Conjunctival Redness at 16 Hours Duration of Action
NCT01697969 (1) [back to overview]Patient-Assessed Ocular Itching
NCT01698814 (1) [back to overview]Adverse Events
NCT01700192 (7) [back to overview]Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
NCT01700192 (7) [back to overview]Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
NCT01700192 (7) [back to overview]Number of Participants Who Discontinue Study Drug Due to an AE
NCT01700192 (7) [back to overview]Number of Participants Who Experience At Least One Adverse Event (AE)
NCT01700192 (7) [back to overview]Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
NCT01700192 (7) [back to overview]Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
NCT01700192 (7) [back to overview]Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
NCT01732757 (11) [back to overview]Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
NCT01732757 (11) [back to overview]Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
NCT01732757 (11) [back to overview]Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
NCT01743027 (8) [back to overview]Mean Conjunctival Redness at 24 Hours Duration of Action
NCT01743027 (8) [back to overview]Mean Conjunctival Redness at Onset of Action
NCT01743027 (8) [back to overview]Mean Ocular Itching at 24 Hours Duration of Action
NCT01743027 (8) [back to overview]Proportion of Ocular Itching Responders at Onset of Action
NCT01743027 (8) [back to overview]Mean Ocular Itching at Onset of Action
NCT01743027 (8) [back to overview]Mean Total Redness at 24 Hours Duration of Action
NCT01743027 (8) [back to overview]Mean Total Redness at Onset of Action
NCT01743027 (8) [back to overview]Proportion of Itch Responders at 24 Hours Duration of Action
NCT02161146 (2) [back to overview]Ocular Itching Score
NCT02161146 (2) [back to overview]Conjunctival Hyperemia Score
NCT02251613 (2) [back to overview]Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
NCT02251613 (2) [back to overview]Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
NCT02318303 (1) [back to overview]Change in rTNSS From Baseline to End of Treatment
NCT02322216 (1) [back to overview]Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
NCT02478398 (7) [back to overview]Average Rhinoconjunctivitis (RC) DMS During the Peak RS
NCT02478398 (7) [back to overview]Average Rhinoconjunctivitis (RC) DSS During the Peak RS
NCT02478398 (7) [back to overview]Average TCS During the Entire RS
NCT02478398 (7) [back to overview]Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions
NCT02478398 (7) [back to overview]Percentage of Participants Treated With Epinephrine
NCT02478398 (7) [back to overview]Total Combined Score (TCS) During the Peak Ragweed Season (RS)
NCT02478398 (7) [back to overview]Percentage of Participants Reporting Pre-specified Local Application Site Reactions
NCT02631551 (1) [back to overview]Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.

Change in Ocular Itch Score From Baseline

Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes. (NCT00534794)
Timeframe: 0 hours, 12 hours

Interventionunits on a scale (Mean)
Elestat-1.5
Pataday-1.5

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Ocular Comfort Score at 12 Hours

Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. (NCT00534794)
Timeframe: 12 hours

Interventionunits on a scale (Mean)
Elestat8.6
Pataday8.5

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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS

The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.45
Placebo1.77

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Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS

The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst). (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972433.71
Placebo4.91

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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS

The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972430.91
Placebo1.33

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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication. (NCT00550550)
Timeframe: From the Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972434.62
Placebo6.25

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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS

The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.25
Placebo1.70

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Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS

The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972433.83
Placebo4.69

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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS

The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.30
Placebo1.57

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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972435.08
Placebo6.39

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Average Number of Days of Rescue Medication Taken

(NCT00578331)
Timeframe: Month 1 through Month 12

InterventionDays (Mean)
Placebo Nasal Spray10.2
Olopatadine 0.6% Nasal Spray11.8

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Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire

Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief. (NCT00578331)
Timeframe: day 30

InterventionUnit on PRRA scale (Mean)
Placebo Nasal Spray2.7
Olopatadine 0.6% Nasal Spray2.5

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Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)

"Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days." (NCT00578929)
Timeframe: Baseline through 2 weeks after randomization

InterventionPercent change of TOSS from baseline (Least Squares Mean)
Olopatadine 0.6% 1 Spray-25.02
Vehicle 1 Spray-6.09
Olopatadine 0.6% 2 Sprays-25.03
Vehicle 2 Sprays-9.46

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Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)

"Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days." (NCT00578929)
Timeframe: Baseline through 2 weeks after randomization

InterventionPercent change of TNSS from baseline (Least Squares Mean)
Olopatadine 0.6% 1 Spray-25.10
Vehicle 1 Spray-18.17
Olopatadine 0.6% 2 Sprays-26.35
Vehicle 2 Sprays-21.21

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Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion

"Outcome:~The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay.~Eosinophils in eosinophils / square cm measured." (NCT00609128)
Timeframe: 1 week for tear collection, tears stored at - 80 C until used

Interventioneosinophils/square cm epithelial cells (Mean)
Tears From Olopatadine Treated Eyes4517
Tears From Untreated Eyes5004

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Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline

Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing. (NCT00691665)
Timeframe: 14 days minus baseline

InterventionPercent change (Mean)
Olopatadine HCL Nasal Spray, 0.6%-45.26
Fluticasone Propionate Nasal Spray, 50 Mcg-48.8

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Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline

Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing. (NCT00691665)
Timeframe: 14 Days minus baseline

InterventionPercent change (Mean)
Olopatadine HCL Nasal Spray, 0.6%-36.54
Fluticasone Propionate Nasal Spray, 50 Mcg-41.63

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Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline

Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00691665)
Timeframe: 14 Days minus baseline

InterventionPercent change (Mean)
Olopatadine HCL Nasal Spray, 0.6%-45.37
Fluticasone Propionate Nasal Spray, 50 Mcg-47.35

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Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline

Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00691665)
Timeframe: 14 Days minus baseline

InterventionPercent change (Mean)
Olopatadine HCL Nasal Spray, 0.6%-38.52
Fluticasone Propionate Nasal Spray, 50 Mcg-40.59

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Product Preference Questionnaire for Immediate Taste

Using a set of coded responses, subjects evaluated product preference in regards to immediate taste (NCT00772304)
Timeframe: 5 min post-dose

InterventionPercentage of participants (Number)
Preferred Azelastine StronglyPreferred Azelastine SomewhatPreferred Azelastine SlightlySamePreferred Olopatadine SlightlyPreferred Olopatadine SomewhatPreferred Olopatadine Strongly
Olopatadine 0.6% / Azelastine 137 Mcg26.4710.785.8815.698.828.8223.53

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The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.

(NCT00775658)
Timeframe: at baseline and at return visit (between study day 7-10)

Interventioncm2 (Mean)
Olopatadine6.95
Placebo8.31

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The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.

(NCT00775658)
Timeframe: at baseline and at return visit (between study day 7-10)

Interventioncm2 (Mean)
Olopatadine0.461
Placebo0.464

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Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)

Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes. (NCT00789555)
Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

,,
InterventionPercentage of subjects (Number)
Decrease greater than 30 BPMDecrease 21-30 BPMDecrease 11-20 BPMDecrease 1-10 BPMNo ChangeIncrease 1-10 BPMIncrease 11-20 BPMIncrease 21-30 BPMIncrease greater than 30 BPM
PATANASE0.00.77.527.27.538.716.81.40.2
Patanase Vehicle, pH 3.70.01.29.230.46.538.99.93.60.2
Patanase Vehicle, pH 7.00.00.56.234.77.939.78.91.40.7

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Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)

Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. (NCT00789555)
Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

,,
InterventionPercentage of subjects (Number)
Anatomic AbnormalitiesBleedingInfectionPossible Ulcerations
PATANASE0.80.80.30.5
Patanase Vehicle, pH 3.71.31.01.00.5
Patanase Vehicle, pH 7.00.32.60.01.6

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Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)

Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. (NCT00789555)
Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

,,
InterventionPercentage of subjects (Number)
Head/EENTNeckCardiovascularPulmonaryAbdomenSkin and ExtremitiesNeurologicalLymph NodesMusculoskeletal
PATANASE5.20.00.00.70.01.20.70.00.0
Patanase Vehicle, pH 3.74.20.70.50.20.00.50.00.20.5
Patanase Vehicle, pH 7.04.60.00.30.30.31.30.00.00.5

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Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)

Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure. (NCT00789555)
Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

,,
InterventionPercentage of subjects (Number)
Decrease greater than 30 mmHgDecrease 21-30 mmHgDecrease 11-20 mmHgDecrease 1-10 mmHgNo changeIncrease 1-10 mmHgIncrease 11-20 mmHgIncrease 21-30 mmHgIncrease greater than 30 mmHg
PATANASE0.51.011.835.34.635.110.61.20.0
Patanase Vehicle, pH 3.71.22.49.236.35.333.410.21.90.0
Patanase Vehicle, pH 7.00.52.410.035.45.334.410.51.20.2

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Self-Rated Relief Assessment at Day 30

"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief." (NCT00789555)
Timeframe: Day 30

InterventionUnits on a scale (Mean)
PATANASE2.4
Patanase Vehicle, pH 3.72.7
Patanase Vehicle, pH 7.02.7

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Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)

Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure. (NCT00789555)
Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

,,
InterventionPercentage of subjects (Number)
Decrease greater than 30 mmHgDecrease 21-30 mmHgDecrease 11-20 mmHgDecrease 1-10 mmHgNo changeIncrease 1-10 mmHgIncrease 11-20 mmHgIncrease 21-30 mmHgIncrease greater than 30 mmHg
PATANASE0.00.78.744.57.533.25.30.20.0
Patanase Vehicle, pH 3.70.21.013.638.76.133.46.50.50.0
Patanase Vehicle, pH 7.00.20.511.542.66.533.75.00.00.0

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Number of Participants With Anatomic Nasal Exam Abnormalities

The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa (NCT00794144)
Timeframe: Day 1 (Baseline) to Exit

InterventionParticipants (Number)
Olopatadine Hydrochloride Nasal Spray 0.6%3
Olopatadine Hydrochloride Nasal Spray Vehicle2

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"Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire"

Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching. (NCT00818805)
Timeframe: 0-180 minutes after entering the examination room

,,,
InterventionUnits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes75 minutes90 minutes105 minutes120 minutes135 minutes150 minutes165 minutes180 minutes
Olopatadine 0.1% One Eye0.190.440.500.670.810.920.941.031.171.251.281.39
Placebo (Olopatadine)0.060.330.500.750.920.921.031.191.331.361.391.44
Placebo (Tranilast)0.080.280.560.610.780.940.971.081.191.251.331.47
Tranilast 0.5% One Eye0.110.250.360.500.670.860.861.031.141.141.141.39

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Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline

Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing. (NCT00845195)
Timeframe: 14 days minus baseline

InterventionUnits on a scale (Mean)
Olopatadine HCl Nasal Spray, 0.6%2.76
Azelastine HCl Nasal Spray, 0.1%2.54

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Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline

Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication. (NCT00845195)
Timeframe: 14 days minus baseline

InterventionUnits on a scale (Mean)
Olopatadine HCl Nasal Spray, 0.6%4.28
Azelastine HCl Nasal Spray, 0.1%4.15

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Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline

Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication. (NCT00845195)
Timeframe: 14 days minus baseline

InterventionUnits on a scale (Mean)
Olopatadine HCl Nasal Spray, 0.6%4.22
Azelastine HCl Nasal Spray, 0.1%4.04

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Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline

Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing. (NCT00845195)
Timeframe: 14 days minus baseline

InterventionUnits on a scale (Mean)
Olopatadine HCl Nasal Spray, 0.6%2.64
Azelastine HCl Nasal Spray, 0.1%2.49

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Mean Change Postnasal Drip Reflective Score

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00979615)
Timeframe: 2 Weeks

InterventionUnits on a scale (Mean)
Olopatadine HCL1.5
Azelastine HCl1.8

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Mean Change Nasal Congestion Reflective Score

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00979615)
Timeframe: 2 Weeks

InterventionUnits on a scale (Mean)
Olopatadine HCL1.4
Azelastine HCl1.7

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Mean Change in Sneezing Reflective Score

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00979615)
Timeframe: 2 Weeks

InterventionUnits on a scale (Mean)
Olopatadine HCL1.4
Azelastine HCl1.7

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Mean Change in Rhinorrhea Reflective Score

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00979615)
Timeframe: 2 week

InterventionUnits on a scale (Mean)
Olopatadine HCL1.5
Azelastine HCl1.3

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Mean Change in 2-week rTNSS From Baseline

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. (NCT00979615)
Timeframe: 2 week

InterventionUnits on a scale (Mean)
Olopatadine HCL5.9
Azelastine HCl6.5

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Total Number of Eosinophils

The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils. (NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

Interventioneosinophils (Median)
PL/PL7883
FF/PL238
PL/OLO9606
FF/OLO311

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Total Number of Sneezes

(NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

Interventionsneezes (Median)
PL/PL10
FF/PL2.5
PL/OLO2.5
FF/OLO1.0

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Total Nasal Symptoms Score Difference

After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36. (NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

Interventionunits on a scale (Median)
PL/PL17
FF/PL10
PL/OLO9
FF/OLO9

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Total Eye Symptoms Score Difference

After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36. (NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

Interventionunits on a scale (Median)
PL/PL6
FF/PL0
PL/OLO2.5
FF/OLO1.5

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Change in Tryptase Level (Across Nasal Challenges)

"Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.~For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient." (NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

Interventionng/mL (Median)
PL/PL5
FF/PL0
PL/OLO2
FF/OLO0

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Change in Histamine Level (Across Nasal Challenges)

"Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.~Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.~For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient." (NCT01007253)
Timeframe: 50 minutes [duration of 3 nasal challenges and 2 washout periods]

InterventionnM (Median)
PL/PL5.9
FF/PL0.3
PL/OLO11.4
FF/OLO3.4

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Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo

Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison. (NCT01119287)
Timeframe: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)

,,,
Interventionhours x units on a scale (Mean)
Baseline (Visit 3, pre-treatment)Visit 6 (Day 9 of treatment)Change
Maxidex/Cat Allergic16.82311.313-5.511
Maxidex/Ragweed Allergic18.12011.671-6.450
Tears Naturale II/Cat Allergic17.57213.824-3.748
Tears Naturale II/Ragweed Allergic19.36215.786-3.576

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Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo

Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison. (NCT01119287)
Timeframe: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)

,,,
Interventionhours x units on a scale (Mean)
Baseline (Visit 2, pre-treatment)Visit 5 (Day 8 of treatment)Change
Patanol/Cat Allergic5.9042.881-3.023
Patanol/Ragweed Allergic4.7762.630-2.146
Tears Naturale II/Cat Allergic5.6542.586-3.068
Tears Naturale II/Ragweed Allergic5.6693.990-1.680

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Overall Patient Satisfaction

"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied." (NCT01159769)
Timeframe: Day 7

InterventionPercentage of Participants (Number)
Olopatadine 0.2%89.3

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Overall Patient Satisfaction

"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied." (NCT01159769)
Timeframe: Day 0

InterventionPercentage of Participants (Number)
Olopatadine 0.2%70.1

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Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours

As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. (NCT01282138)
Timeframe: Baseline, 3 hours

InterventionUnits on a scale (Mean)
Patanol-1.63
Tears Naturale II-1.11

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Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours

As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. (NCT01282138)
Timeframe: Baseline, 3 hours

InterventionUnits on a scale (Mean)
Patanol-0.38
Tears Naturale II-1.15

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Mean Hyperemia Score Compared to Olopatadine Period2

"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ." (NCT01363700)
Timeframe: Visit 7 (5, 10, and 20 minutes post-CAC)

Interventionscore (Mean)
Epinastine (DE-114) Ophthalmic Solution2.4
Olopatadine Ophthalmic Solution2.7
Placebo Ophthalmic Solution3.7

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Mean Hyperemia Score Compared to Placebo Period1

"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ." (NCT01363700)
Timeframe: Visit 5 (5, 10, and 20 minutes post-CAC)

Interventionscore (Mean)
Epinastine (DE-114) Ophthalmic Solution2.7
Placebo Ophthalmic Solution4.1

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Mean Ocular Itching Score Compared to Olopatadine Period2

"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ." (NCT01363700)
Timeframe: Visit 7 (3, 5, and 10 minutes post-CAC)

Interventionscore (Mean)
Epinastine (DE-114) Ophthalmic Solution0.2
Olopatadine Ophthalmic Solution0.2
Placebo Ophthalmic Solution1.5

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Mean Ocular Itching Score Compared to Placebo Period1

"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ." (NCT01363700)
Timeframe: Visit 5 (3, 5, and 10 minutes post-CAC)

Interventionscore (Mean)
Epinastine (DE-114) Ophthalmic Solution0.4
Placebo Ophthalmic Solution1.7

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Bulbar Conjunctival Injection

Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe (NCT01435460)
Timeframe: Change from baseline to day 15 (visit 3)

Interventionunits on a scale (Mean)
Alrex-1.91
Patanol-1.71

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Ocular Itching

Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe (NCT01435460)
Timeframe: Change from baseline to day 15 (visit 3)

Interventionunits on a scale (Mean)
Alrex-3.74
Patanol-3.28

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Ocular Itching

Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe (NCT01435460)
Timeframe: Change from baseline to day 8 (visit 2)

Interventionunits on a scale (Mean)
Alrex-2.46
Patanol-2.02

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Bulbar Conjunctival Injection

Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe (NCT01435460)
Timeframe: Change from baseline to day 8 (visit 2)

Interventionunits on a scale (Mean)
Alrex-1.36
Patanol-1.18

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Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)1.361.641.67
Pataday™ (Olopatadine 0.2%)1.471.671.65
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)1.832.001.94

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Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)1.742.011.99
Pataday™ (Olopatadine 0.2%)1.782.011.92
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.082.222.20

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Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)1.651.951.91
Pataday™ (Olopatadine 0.2%)1.561.821.79
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.012.152.13

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Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)0.40.50.6
Pataday™ (Olopatadine 0.2%)0.40.60.6
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)1.01.01.1

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Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)0.30.50.5
Pataday™ (Olopatadine 0.2%)0.40.60.6
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)1.00.90.8

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Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24

Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
3 Minutes5 Minutes7 Minutes
LASTACAFT® (Alcaftadine 0.25%)0.640.840.93
Pataday™ (Olopatadine 0.2%)0.971.161.01
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.272.191.96

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Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16

Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching. (NCT01470118)
Timeframe: Day 0 Hour 16

,,
InterventionScores on a Scale (Mean)
3 Minutes5 Minutes7 Minutes
LASTACAFT® (Alcaftadine 0.25%)0.620.931.07
Pataday™ (Olopatadine 0.2%)1.011.131.12
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.142.352.20

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Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis. (NCT01470118)
Timeframe: Day 14 Hour 24

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
LASTACAFT® (Alcaftadine 0.25%)0.901.031.14
Pataday™ (Olopatadine 0.2%)0.971.091.13
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)1.151.341.42

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Mean Conjunctival Redness at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. (NCT01479374)
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment

,,
InterventionUnits on a scale (Mean)
7 min post-CAC15 min post-CAC20 min post-CAC
AL-4943A1.51.81.8
Pataday1.92.12.1
Vehicle2.12.32.3

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Mean Conjunctival Redness at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. (NCT01479374)
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment

,,
InterventionUnits on a scale (Mean)
7 min post-CAC15 min post-CAC20 min post-CAC
AL-4943A0.81.11.1
Pataday1.31.91.9
Vehicle2.12.32.3

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Mean Ocular Itching at 16 Hours Duration of Action

A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. (NCT01479374)
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment

,,
InterventionUnits on a scale (Mean)
3 min post-CAC5 min post-CAC7 min post-CAC
AL-4943A0.70.80.8
Pataday0.91.11.0
Vehicle2.22.32.1

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Mean Ocular Itching at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. (NCT01479374)
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment

,,
InterventionUnits on a scale (Mean)
3 min post-CAC5 min post-CAC7 min post-CAC
AL-4943A0.91.11.1
Pataday1.41.51.5
Vehicle2.52.62.5

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Mean Ocular Itching at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. (NCT01479374)
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment

,,
InterventionUnits on a scale (Mean)
3 min post-CAC5 min post-CAC7 min post-CAC
AL-4943A0.40.60.5
Pataday0.40.70.7
Vehicle1.92.12.0

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Mean Total Redness at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed. (NCT01479374)
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment

,,
InterventionUnits on a scale (Mean)
7 min post-CAC15 min post-CAC20 min post-CAC
AL-4943A4.15.05.4
Pataday5.46.26.3
Vehicle6.16.76.6

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Mean Conjunctival Redness at 16 Hours Duration of Action

A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. (NCT01479374)
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment

,,
InterventionUnits on a scale (Mean)
7 min post-CAC15 min post-CAC20 min post-CAC
AL-4943A1.31.51.5
Pataday1.61.91.9
Vehicle1.81.91.9

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Patient-Assessed Ocular Itching

The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment. (NCT01697969)
Timeframe: Baseline (Day 1), Day 14

,
Interventionunits on a scale (Mean)
Baseline (Day 1)Day 14 (n=11)
Left Eye2.20.5
Right Eye2.20.5

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Adverse Events

An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. (NCT01698814)
Timeframe: An average of 6 weeks

,
Interventionparticipants (Number)
DeathsNon-Fatal Serious Adverse EventsDiscontinuations Due to an Adverse Event
AL-4943A000
AL-4943A Vehicle002

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Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment

The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

InterventionScore on a Scale (Mean)
MK-82374.67
Placebo5.49

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Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment

The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

InterventionScore on a Scale (Mean)
MK-82376.40
Placebo7.62

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Number of Participants Who Discontinue Study Drug Due to an AE

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 52 weeks

InterventionParticipants (Number)
MK-823773
Placebo19

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Number of Participants Who Experience At Least One Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 54 weeks

InterventionParticipants (Number)
MK-8237676
Placebo539

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Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment

The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

InterventionScore on a Scale (Mean)
MK-82370.84
Placebo1.03

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Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment

"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)." (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

InterventionScore on a Scale (Mean)
MK-823742.29
Placebo47.96

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Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment

The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

InterventionScore on a Scale (Mean)
MK-82373.83
Placebo4.46

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Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0

Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching. (NCT01732757)
Timeframe: Day 0 at 3 Minutes Post Challenge

InterventionScores on a Scale (Mean)
Lastacaft®0.40
Pataday™0.76
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.00

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Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0

Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®0.370.620.73
Pataday™0.270.510.56
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)0.510.760.96

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Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0

Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®1.621.972.06
Pataday™1.471.711.78
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.102.122.13

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Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0

The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®1.732.022.10
Pataday™1.611.811.89
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.172.172.22

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Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0

The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®1.611.881.97
Pataday™1.531.701.78
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.042.042.09

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Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0

Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®0.20.40.4
Pataday™0.30.50.6
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)0.80.90.7

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Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0

Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
5 Minutes7 Minutes
Lastacaft®0.610.69
Pataday™0.790.71
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)2.081.89

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Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0

Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). (NCT01732757)
Timeframe: Day 0

,,
InterventionPercentage of Subject Eyes (Number)
00.51.01.52.02.53.03.54.0
Lastacaft®41.732.112.53.55.84.20.30.00.0
Pataday™34.324.020.87.76.75.11.30.00.0
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)8.710.98.06.417.922.815.15.84.5

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Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0

Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0. (NCT01732757)
Timeframe: Day 0

,,
InterventionPercentage of Subjects (Number)
3 Minutes5 Minutes7 Minutes
Lastacaft®48.126.926.9
Pataday™26.926.932.7
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)5.83.87.7

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Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0

Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1. (NCT01732757)
Timeframe: Day 0

,,
InterventionPercentage of Subjects (Number)
3 Minutes5 Minutes7 Minutes
Lastacaft®84.675.069.2
Pataday™65.453.861.5
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)21.221.225.0

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Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0

Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing. (NCT01732757)
Timeframe: Day 0

,,
InterventionScores on a Scale (Mean)
7 Minutes15 Minutes20 Minutes
Lastacaft®0.20.40.3
Pataday™0.40.50.6
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)0.90.80.7

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Mean Conjunctival Redness at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. (NCT01743027)
Timeframe: Day 1 (7, 15, and 20 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
AL-4943A1.922.042.08
PATADAY2.012.212.19
PATANOL1.972.102.07
Vehicle2.092.222.23

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Mean Conjunctival Redness at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. (NCT01743027)
Timeframe: Day 14 (7, 15, and 20 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
AL-4943A1.341.651.66
PATADAY1.621.961.97
PATANOL1.651.971.97
Vehicle1.962.102.15

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Mean Ocular Itching at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. (NCT01743027)
Timeframe: Day 1 (3, 5, and 7 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
AL-4943A1.011.221.25
PATADAY1.331.481.41
PATANOL1.531.701.64
Vehicle2.302.372.14

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Proportion of Ocular Itching Responders at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. (NCT01743027)
Timeframe: Day 14

Interventionpercentage of participants (Number)
AL-4943A71.4
PATADAY73.7
PATANOL59.6
Vehicle10.2

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Mean Ocular Itching at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. (NCT01743027)
Timeframe: Day 14 (3, 5, and 7 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
AL-4943A0.380.530.65
PATADAY0.470.610.61
PATANOL0.590.790.83
Vehicle1.911.991.82

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Mean Total Redness at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. (NCT01743027)
Timeframe: Day 1 (7, 15, and 20 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
AL-4943A5.395.876.00
PATADAY5.776.426.41
PATANOL5.666.116.02
Vehicle6.126.496.49

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Mean Total Redness at Onset of Action

A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. (NCT01743027)
Timeframe: Day 14 (7, 15, and 20 minutes post-CAC)

,,,
Interventionunits on a scale (Least Squares Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
AL-4943A3.924.804.96
PATADAY4.735.735.88
PATANOL4.825.855.88
Vehicle5.936.506.67

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Proportion of Itch Responders at 24 Hours Duration of Action

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. (NCT01743027)
Timeframe: Day 1

Interventionpercentage of participants (Number)
AL-4943A40.8
PATADAY30.3
PATANOL26.3
Vehicle4.1

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Ocular Itching Score

Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged. (NCT02161146)
Timeframe: Days 1 and 15

Interventionscore on a scale (Mean)
AGN-2296660.33
Vehicle1.48
Olopatadine0.29

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Conjunctival Hyperemia Score

Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged. (NCT02161146)
Timeframe: Days 1 and 15

Interventionscore on a scale (Mean)
AGN-2296661.15
Vehicle1.61
Olopatadine1.34

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Mean Ocular Itching at 7 Minutes Post-CAC, Day 1

A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub). (NCT02251613)
Timeframe: Day 1, 7 minutes post-CAC

Interventionunits on a scale (Mean)
Olopatadine 0.1%0.23
Epinastine 0.05%0.37

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Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1

A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe). (NCT02251613)
Timeframe: Day 1, 20 minutes post-CAC

Interventionunits on a scale (Mean)
Olopatadine 0.1%0.89
Epinastine 0.05%1.12

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Change in rTNSS From Baseline to End of Treatment

"Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.~The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.~The severity scale for each symptom evaluation was defined as follows:~0 = absent (no sign/symptom evident)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])" (NCT02318303)
Timeframe: 14 days

,,,,,,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Visit 4
GSP 301 Placebo10.3-1.4
GSP 301-1 NS (QD)10.4-2.5
GSP 301-2 NS (BID)10.4-2.6
Mometasone Furoate-1 NS (QD)10.4-2.2
Mometasone Furoate-2 NS (BID)10.5-1.9
Olopatadine HCl-1 NS (QD)10.3-1.7
Olopatadine HCl-2 NS (BID)10.3-2.1

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Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14

Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. (NCT02322216)
Timeframe: Baseline, Day 14

Interventionunits on a scale (Mean)
PATADAY-2.57
PATANOL-2.62

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Average Rhinoconjunctivitis (RC) DMS During the Peak RS

This DMS endpoint consists of a total of scores for use of RC medications: loratadine syrup or tablets (6 points), olopatadine (6 points), and mometasone (8 points). The score range of the RC DMS is 0-20 points, and a lower DMS means that less medication is used. The method used for analysis of the RC DMS is a zero-inflated log-normal model, which takes the average RC DMS during the peak RS as the response and adjusts for the same terms as in the ANOVA model. The components that contribute to the DMS endpoint are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average

InterventionScore on a scale (Mean)
Short Ragweed Pollen Allergen Extract2.01
Placebo3.85

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Average Rhinoconjunctivitis (RC) DSS During the Peak RS

The DSS consists of a total of 6 rhinoconjunctivitis symptoms: 4 rhinitis symptoms (runny nose, stuffy nose, sneezing, itchy nose) and 2 conjunctivitis symptoms (itchy eyes, watery eyes). The components that contribute to the DSS endpoint are collected in an e-diary completed by the participant/parent/guardian. The RC DSS is measured on a 4-point scale from 0 to 3 as follows: 0 (no sign/symptom evident) to 3 (sign/symptom that is hard to tolerate; may cause interference with activities of daily living and/or sleeping). The maximum DSS is 18 points if a participant experiences all 6 symptoms with an intensity of 3 for each symptom. The minimum DSS is 0 points if a participant experiences no symptoms. A lower DSS means symptoms are less severe. The evaluation is based on the average DSS during the peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract2.55
Placebo3.95

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Average TCS During the Entire RS

TCS is DSS plus DMS, assessed here during the entire RS. This starts from the first day of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3 through the last day of the last occurrence of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3. The duration of the entire RS is up to 13 weeks; this duration varies by site/region. The RC DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (score range: 0-18). A lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone) with different scores/dose unit (score range: 0-20). A lower DMS indicates less RC medication use. The sum of RC DSS+DMS ranges from 0 to 38, with a lower score indicating less RC symptoms and medication use. Components contributing to the TCS for the entire RS are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: Up to 13 weeks

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract3.88
Placebo5.75

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Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions

For the purposes of this study, systemic allergic reactions are allergic reactions that occur away from the site of study drug application (allergic reactions other than local application site reactions). Anaphylaxis is a severe allergic reaction that typically involves more than one body system. (NCT02478398)
Timeframe: Up to 35 weeks

InterventionPercentage of Participants (Number)
Short Ragweed Pollen Allergen Extract0.58
Placebo0.20

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Percentage of Participants Treated With Epinephrine

Self-injectable epinephrine was provided to each participant/parent/guardian at randomization in countries where it is a regulatory requirement, and was to be available around the time treatment is administered at home. Self-injectable epinephrine was intended for immediate self-administration for an anaphylactic reaction, including symptoms/signs of upper airway obstruction. Instances of treatment with forms of epinephrine other than systemic epinephrine (e.g., inhaled racepinephrine) were counted as use of epinephrine. (NCT02478398)
Timeframe: Up to 35 weeks

InterventionPercentage of Participants (Number)
Short Ragween Pollen Allergen Extract0.19
Placebo0.20

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Total Combined Score (TCS) During the Peak Ragweed Season (RS)

TCS is daily symptom score (DSS) plus daily medication score (DMS), assessed in the peak RS (15 consecutive RS days with the highest 15-day average pollen count). The rhinoconjunctivitis (RC) DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone), with different rescue medications being assigned different scores/dose unit (score range: 0-20). Lower DMS indicates less RC medication use. Summed RC DSS+DMS could range from 0 to 38; a lower score indicates less RC symptoms and medication use. Components that contribute to DSS and DMS endpoints are collected in an electronic diary (e-diary) completed by the participant/parent/guardian. Evaluation is based on average TCS during peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract4.39
Placebo7.12

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Percentage of Participants Reporting Pre-specified Local Application Site Reactions

Pre-specified local application site reactions, irrespective of causality, included AEs related to lip swelling/edema, mouth swelling/edema, palatal swelling/edema, swollen tongue/edema, oropharyngeal swelling/edema, pharyngeal edema/throat tightness, oral pruritus, throat irritation, tongue pruritus, and ear pruritus. (NCT02478398)
Timeframe: Up to 35 weeks

InterventionPercentage of Participants (Number)
Short Ragween Pollen Allergen Extract64.52
Placebo26.92

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Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.

Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). (NCT02631551)
Timeframe: 14 days

,,,
Interventionunits on a scale (Mean)
BaselineChange from baseline to end of treatment
GSP 301 NS10.1-3.6
GSP 301 Placebo NS10.2-2.8
Mometasone Furoate NS10.2-3.5
Olopatadine HCl NS10.3-3.2

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