The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

This study is currently recruiting participants.

Verified by Inspire Pharmaceuticals, February 2009

First Received: January 27, 2009 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00831662

Purpose

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

Condition	Intervention	Phase
Dry Eye Disease	Drug: Diquafosol tetrasodium ophthalmic solution, 2% Drug: Placebo	Phase III

MedlinePlus related topics: Eye Diseases

Drug Information available for: Diquafosol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Drug: Placebo One to two drops in each eye QID for 6 weeks
Arm 1: Experimental	Drug: Diquafosol tetrasodium ophthalmic solution, 2% One to two drops in each eye QID for 6 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Have best corrected visual acuity in both eyes of at least +0.7 or better
Central corneal staining of 3 on the NEI scale
If female, are non-pregnant or non-lactating
Have a history of dry eye disease in both eyes
Have normal lid anatomy

Exclusion Criteria:

Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
Have had ocular surface surgery within the past year
Are considered legally blind in one eye
Have a serious medical condition which could confound study assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831662

Contacts

Contact: Saiid Davari

919-941-9777

Locations

United States, California
Sall Research Medical Center	Recruiting
Artesia, California, United States, 90701
Principal Investigator: Kenneth Sall, MD
North Bay Eye Associates, Inc.	Recruiting
Petaluma, California, United States, 94954
Contact: Jason Bacharach, MD
Principal Investigator: Jason Bacharach, MD
United States, Illinois
Chicago Cornea Consultants, Ltd.	Recruiting
Hoffman Estates, Illinois, United States, 60169
Principal Investigator: Parag A Majmudar, MD
United States, Minnesota
Minnesota Eye Consultants, P.A.	Recruiting
Minneapolis, Minnesota, United States, 55404
Principal Investigator: David R Hardten, MD
United States, Missouri
Comprehensive Eye Care Center	Recruiting
Washington, Missouri, United States, 63090
Principal Investigator: Michael S Korenfeld, MD
United States, Ohio
Abrams Eye Center	Recruiting
Cleveland, Ohio, United States, 44115
Principal Investigator: Marc A Abrams, MD, PhD
United States, Pennsylvania
Philadelphia Eye Associates	Recruiting
Philadelphia, Pennsylvania, United States, 19148
Principal Investigator: Joseph I Markoff, PhD, MD
United States, South Dakota
Black Hills Regional Eye Institute	Recruiting
Rapid City, South Dakota, United States, 57701-7394
Principal Investigator: Monte S Dirks, MD
United States, Texas
Corona Research Clinical Study	Recruiting
El Paso, Texas, United States, 79904
Principal Investigator: William F. Davitt, III, MD
Corona Research Consultants, Inc	Recruiting
San Antonio, Texas, United States, 78221
Principal Investigator: Jose Luis Perez-Becerra, MD

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Reza Haque, MD, PhD

Medical Monitor, Inspire

More Information

No publications provided

Responsible Party:	Inspire ( Saiid Davari )
Study ID Numbers:	03-113
Study First Received:	January 27, 2009
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00831662 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases

Additional relevant MeSH terms:

Eye Diseases

ClinicalTrials.gov processed this record on May 06, 2009