CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 188 enrolled
Drug / intervention
Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% +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.

Search/NCT05579730
NCT05579730Phase 3Completed
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Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model

Bausch & Lomb Incorporated·interventional·Posted Oct 14, 2022·Updated Feb 14, 2025

In Brief

A Phase 3 clinical trial evaluating Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%, Brimonidine Tartrate 0.025%, and 2 other interventions for Allergic Conjunctivitis. Completed, enrolled 188 participants across 4 sites.

Detailed Summary

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedOct 14, 2022
Enrollment StartOct 12, 2022
Primary CompletionJul 22, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.7 years ago

Interventions

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%drug

combination ophthalmic solution

Brimonidine Tartrate 0.025%drug

ophthalmic Solution

Ketotifen Fumarate 0.035%drug

ophthalmic Solution

Vehicledrug

ophthalmic Solution