Overview

Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- best corrected visual acuity in both eyes of at least +0.7

- six-month documented history of dry eye disease

- as least mild severity in 1 of the 5 dry eye symptoms

- corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6
(out of 15)

Exclusion Criteria:

- permanent conjunctival goblet cell loss or scarring conditions

- ongoing contact lens wear

- current topical ophthalmic medication use