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

This study has been completed.

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

Sponsor:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

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

Inspire Pharmaceuticals

More Information

No publications provided

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

Additional relevant MeSH terms:

Eye Diseases

ClinicalTrials.gov processed this record on November 27, 2009