A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

Study Overview
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Brief Summary
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To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Official Title
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A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle 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 0.2%
* Drug: Bilastine 0.4%
* Drug: Bilastine 0.6%
* Drug: Bilastine 0%


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilastine 0.2%<br>Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period. | Drug: Bilastine 0.2%<br>* 1 drop in each eye at 3 separate times during a 25 day period.<br>|
| Experimental: Bilastine 0.4%<br>Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period. | Drug: Bilastine 0.4%<br>* 1 drop in each eye at 3 separate times during a 25 day period.<br>|
| Experimental: Bilastine 0.6%<br>Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period. | Drug: Bilastine 0.6%<br>* 1 drop in each eye at 3 separate times during a 25 day period.<br>|
| Placebo Comparator: Bilastine 0%<br>Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period. | Drug: Bilastine 0%<br>* 1 drop in each eye at 3 separate times during a 25 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 post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch. | The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment). |