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

NCT ID: NCT00403975

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-11-30

Brief 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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

diquafosol tetrasodium ophthalmic solution, 2%

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

03-109

Identifier Type: -

Identifier Source: org_study_id