A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
ClinicalTrials.gov ID
NCT00893139
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
765Actual
Last Update Posted
Jul 15, 2014Estimated
Start Date
Jun 2009
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
Brief Summary
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
Dry Eye
AL-38583 ophthalmic solution 0.05%
AL-38583 ophthalmic solution 0.10%
AL-38583 vehicle
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Composite corneal staining score of greater than 5 in one or both eyes.
Schirmer II score of greater than 4 mm.
OSDI score of greater than 23.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
Other protocol-defined exclusion criteria may apply.