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

This study has been completed.

First Received on November 22, 2006. Last Updated on November 24, 2006 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00403975

Purpose

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	Intervention	Phase
Dry Eye Disease	Drug: diquafosol tetrasodium ophthalmic solution, 2%	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Diquafosol Ins 365

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change in dry eye testing measures

Secondary Outcome Measures:

Change in dry eye testing measures and symptoms

Estimated Enrollment:	520
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403975

Locations

United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176

Sponsors and Collaborators

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00403975 History of Changes
Other Study ID Numbers:	03-109
Study First Received:	November 22, 2006
Last Updated:	November 24, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis

Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on February 12, 2012