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

Phase 3

Completed

• Conditions: Dry Eye Disease

• Registration Number: NCT00403975
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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)

Read More

Exclusion Criteria

• permanent conjunctival goblet cell loss or scarring conditions
• ongoing contact lens wear
• current topical ophthalmic medication use

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in dry eye testing measures

Secondary Outcome Measures

Name	Time	Method
Change in dry eye testing measures and symptoms