At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 229 enrolled
Drug / intervention
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle in an Allergen BioCube® in Subjects With Seasonal Allergic Conjunctivitis
In Brief
A Phase 3 clinical trial evaluating Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035%, and 2 other interventions for Seasonal Allergic Conjunctivitis. Completed, enrolled 229 participants across 6 sites.
Detailed Summary
To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Conjunctivitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartNov 2022
Primary CompletionAug 2023
TodayJul 2026
First PostedOct 24, 2022
Enrollment StartNov 18, 2022
Primary CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.7 years ago
Interventions
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solutiondrug
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Ketotifen fumarate ophthalmic solution 0.035%drug
Ketotifen fumarate ophthalmic solution 0.035%
Brimonidine tartrate ophthalmic solution 0.025%drug
Brimonidine tartrate ophthalmic solution 0.025%
Experimental: Vehicle ophthalmic solutiondrug
Experimental: Vehicle ophthalmic solution