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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00831662
First received: January 27, 2009
Last updated: September 20, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 490
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: Placebo
One to two drops in each eye QID for 6 weeks
Experimental: Arm 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United Medical Research Institute
Inglewood, California, United States, 90302
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
David Wirta, MD, Inc.
Newport Beach, California, United States, 92663
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
Martel Eye Medical Group
Ranchero Cordova, California, United States, 95670
Wolstan Eye Associates
Torrance, California, United States, 90505
United States, Connecticut
Peter C. Donshik, MD, PC
Bloomfield, Connecticut, United States, 06002
Eye Center
Hamden, Connecticut, United States, 06518
United States, Florida
The Eye Associates
Bradenton, Florida, United States, 34209
Hernando Eye Institute
Brooksville, Florida, United States, 34613
Center For Excellence In Eye Care
Miami, Florida, United States, 33176
Marvin E. Greenberg, MD, LLC
Tamarac, Florida, United States, 33321
International Eye Center
Tampa, Florida, United States, 33603
United States, Illinois
Wohl Eye Center
Bloomingdale, Illinois, United States, 60108
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169
United States, Indiana
Price VIsion Group
Indianapolis, Indiana, United States, 46260
IU Eye at Carmel
Indianapolis, Indiana, United States, 46202
United States, Iowa
Eye Physicians and Surgeons, LLP
Iowa City, Iowa, United States, 52245
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Minnesota
Minnesota Eye Consultants, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Ophthalmology Associates
St Louis, Missouri, United States, 63131
Comprehensive Eye Care Center
Washington, Missouri, United States, 63090
United States, Montana
Ophthalmology Consultants, Ltd
Des Peres, Montana, United States, 63131
United States, Nevada
Las Vegas Physicians Research Group
Henderson, Nevada, United States, 89052
United States, New York
Robert Schultze, MD
Delmar, New York, United States, 12054
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Mount Sinai School of Medicine
New York, New York, United States, 10029
South Shore Eye Care, LLP
Wantagh, New York, United States, 11793
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Pennsylvania
Family Eye Group
Lancaster, Pennsylvania, United States, 17601
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148
United States, South Carolina
Glaucoma Consultants and Center for Eye Research, PA
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701-7394
United States, Texas
Eye Clinic of Austin
Austin, Texas, United States, 78731
Corona Research Clinical Study
El Paso, Texas, United States, 79904
MedTex Research
Rosharon, Texas, United States, 77583
Eye Clinics of South Texas
San Antonio, Texas, United States, 78209
Corona Research Consultants, Inc
San Antonio, Texas, United States, 78221
United States, Virginia
See Clearly Vision Group, LLC
McLean, Virginia, United States, 22102
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Canada, New Brunswick
Dr. Donald H. Farrell Ophthalmology
Saint John, New Brunswick, Canada, E2L 1G3
Canada, Ontario
Yorkville Eye Clinic
Toronto, Ontario, Canada, M5R 2G3
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Reza Haque, MD, PhD Medical Monitor, Inspire
  More Information

No publications provided

Responsible Party: Saiid Davari, Inspire
ClinicalTrials.gov Identifier: NCT00831662     History of Changes
Other Study ID Numbers: 03-113, P08637
Study First Received: January 27, 2009
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014