At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 228 enrolled
Drug / intervention
Bilastine Ophthalmic Solution 0.6% +2 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.
A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
In Brief
A Phase 3 clinical trial evaluating Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen), and 1 other intervention for Allergic Conjunctivitis. Completed, enrolled 228 participants across 6 sites.
Detailed Summary
To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 2018
Enrollment StartApr 2018
Primary CompletionAug 2018
Study CompletionAug 2018
TodayJul 2026
First PostedMar 27, 2018
Enrollment StartApr 7, 2018
Primary CompletionAug 9, 2018
Study CompletionAug 10, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.3 years ago
Interventions
Bilastine Ophthalmic Solution 0.6%drug
1 drop in each eye at 2 separate times during an 8 day period.
Ketotifen Ophthalmic Solution 0.025% (Zaditen)drug
1 drop in each eye at 2 separate times during an 8 day period.
Vehicle of Bilastine Ophthalmic Solutiondrug
1 drop in each eye at 2 separate times during an 8 day period.