AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: AL-38583 ophthalmic solution
* Drug: AL-38583 ophthalmic solution vehicle
* Drug: Dexamethasone ophthalmic suspension, 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of signs and symptoms of ocular inflammation in both eyes. Have a positive CAC response at Visit 1. Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Have known history or presence of persistent dry eye syndrome. Presence of any ophthalmic abnormality that may affect the study outcomes. Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study. Other protocol-defined exclusion criteria may apply.

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: AL-38583 0.01%<br>AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks | Drug: AL-38583 ophthalmic solution<br> <br> |
| Experimental: AL-38583 0.05%<br>AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks | Drug: AL-38583 ophthalmic solution<br> <br> |
| Experimental: AL-38583 0.2%<br>AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks | Drug: AL-38583 ophthalmic solution<br> <br> |
| Placebo Comparator: AL-38583 Vehicle<br>AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks | Drug: AL-38583 ophthalmic solution vehicle<br>* Inactive ingredients used as a placebo comparator<br>|
| Active Comparator: MAXIDEX<br>Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks | Drug: Dexamethasone ophthalmic suspension, 0.1%<br> <br> * Other names: MAXIDEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily diary ocular redness scores |  | 2 week period between Day 0 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conjunctivitis, conjunctival inflammation, ocular allergies