AGN-229666 for the Treatment of Allergic Conjunctivitis

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: AGN-229666
* Other: vehicle of AGN-229666


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients living in Japan with a history of allergic conjunctivitis Willing to discontinue wearing contact lenses during the study period Exclusion Criteria: Use of nicotine products during the study period Presence of active eye infection (bacterial, viral, or fungal) History of an ocular herpetic infection Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months

Ages Eligible for Study
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Minimum Age: 20 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: AGN-229666 Dose A<br>One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. | Drug: AGN-229666<br>* One drop of AGN-229666 into each eye on Day 1 and Day 15.<br>|
| Experimental: AGN-229666 Dose B<br>One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. | Drug: AGN-229666<br>* One drop of AGN-229666 into each eye on Day 1 and Day 15.<br>|
| Placebo Comparator: vehicle of AGN-229666<br>One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. | Other: vehicle of AGN-229666<br>* One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Score at Day 1 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Score at Day 15 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Day 15 | 
| Conjunctival Hyperemia Score | Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes. | Day 1 |