AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Overview
- Phase
- Phase 2
- Intervention
- AL-38583 ophthalmic solution
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Alcon Research
- Enrollment
- 312
- Primary Endpoint
- Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Presence of signs and symptoms of ocular inflammation in both eyes.
- •Have a positive CAC response at Visit
- •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.
Arms & Interventions
AL-38583 0.01%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention: AL-38583 ophthalmic solution
AL-38583 0.05%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention: AL-38583 ophthalmic solution
AL-38583 0.2%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention: AL-38583 ophthalmic solution
AL-38583 Vehicle
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention: AL-38583 ophthalmic solution vehicle
MAXIDEX
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention: Dexamethasone ophthalmic suspension, 0.1%
Outcomes
Primary Outcomes
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Time Frame: Day 14
Secondary Outcomes
- Mean daily diary ocular redness scores(2 week period between Day 0 and Day 14)