AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
ClinicalTrials.gov ID
NCT01001091
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
312Actual
Last Update Posted
Jul 17, 2014Estimated
Start Date
Dec 2009
Primary Completion Date
Apr 2010Actual
Completion Date
Apr 2010Actual
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.
Allergic Conjunctivitis
AL-38583 ophthalmic solution
AL-38583 ophthalmic solution vehicle
Dexamethasone ophthalmic suspension, 0.1%
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.