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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00403975
• Collaborator: (none)
• Enrollment: 640
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: diquafosol tetrasodium ophthalmic solution, 2%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 640 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Nov 1, 2004
• Actual Study Completion Date: Nov 1, 2004

Outcome Measures

Primary Outcome Measures

1. Change in dry eye testing measures []

Secondary Outcome Measures

1. Change in dry eye testing measures and symptoms []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00403975
• Other Study ID Numbers: 03-109
• First Posted: Nov 27, 2006
• Last Update Posted: Feb 22, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Ophthalmic Solutions

Study Results

No Results Posted as of Feb 22, 2016