Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Phase 3
Completed
- Conditions
- Dry Eye Disease
- Registration Number
- NCT00404131
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- best corrected visual acuity in both eyes of at least +0.7
- six-month documented history of dry eye disease
- at least mild severity in 2 of the 4 dry eye symptoms
- unanesthetized Schirmer score of less than or equal to 7mm
- corneal fluorescein staining of greater than or equal to 4 (out of 15)
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Exclusion Criteria
- nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
- ongoing contact lens wear
- current topical ophthalmic medication use
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in dry eye testing measures and symptoms
- Secondary Outcome Measures
Name Time Method Change in dry eye testing measures and symptoms