NCT00893139CompletedPhase 2
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 765
- Primary Endpoint
- Mean change from baseline in sodium fluorescein corneal staining score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
AL-38583 0.05%
Experimental
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
Intervention: AL-38583 ophthalmic solution 0.05% (Drug)
AL-38583 0.10%
Experimental
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
Intervention: AL-38583 ophthalmic solution 0.10% (Drug)
AL-38583 vehicle
Placebo Comparator
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
Intervention: AL-38583 vehicle (Drug)
Outcomes
Primary Outcomes
Mean change from baseline in sodium fluorescein corneal staining score
Time Frame: Baseline, up to Day 35
Secondary Outcomes
- Mean change from baseline in phenol red thread length(Baseline, up to Day 35)
Investigators
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