Status:
COMPLETED
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Lead Sponsor:
Alcon Research
Collaborating Sponsors:
Ophthalmic Research Associates, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01001091
Start Date
December 1 2009
End Date
April 1 2010
Last Update
July 17 2014
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