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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: diquafosol tetrasodium ophthalmic solution, 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403975

03-109

Details and patient eligibility

About

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.

Enrollment: 640 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind