A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Bilastine Ophthalmic Solution 0.6%
* Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
* Drug: Vehicle of Bilastine Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years old be willing and able to avoid all disallowed medications and contact lenses must have a pregnancy test if of childbearing potential must be able to read an eye chart from 10 feet away Exclusion Criteria: must not have any allergies to the study medications must not have any ocular or non ocular condition that investigator feels will interfere with study parameters must not have used immunotherapy in the last 2 years must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilastine Ophthalmic Solution 0.6%<br>Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period. | Drug: Bilastine Ophthalmic Solution 0.6%<br>* 1 drop in each eye at 2 separate times during an 8 day period.<br>|
| Active Comparator: Ketotifen Ophthalmic Solution 0.025% (Zaditen)<br>Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period. | Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)<br>* 1 drop in each eye at 2 separate times during an 8 day period.<br>* Other names: Zaditen;|
| Placebo Comparator: Vehicle of Bilastine Ophthalmic Solution<br>Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period. | Drug: Vehicle of Bilastine Ophthalmic Solution<br>* 1 drop in each eye at 2 separate times during an 8 day period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub). | The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment). |