Status:
COMPLETED
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2001
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00404131
Start Date
March 1 2001
End Date
December 1 2001
Last Update
November 29 2016
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