A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
Phase 2
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: AL-38583 ophthalmic solution 0.10%Drug: AL-38583 vehicleDrug: AL-38583 ophthalmic solution 0.05%
- Registration Number
- NCT00893139
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 765
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AL-38583 0.10% AL-38583 ophthalmic solution 0.10% AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days AL-38583 vehicle AL-38583 vehicle Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days AL-38583 0.05% AL-38583 ophthalmic solution 0.05% AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
- Primary Outcome Measures
Name Time Method Mean change from baseline in sodium fluorescein corneal staining score Baseline, up to Day 35
- Secondary Outcome Measures
Name Time Method Mean change from baseline in phenol red thread length Baseline, up to Day 35