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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00403975
First received: November 22, 2006
Last updated: February 21, 2014
Last verified: February 2014
  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 3

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:


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

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
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  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
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: NCT00403975

Locations
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00403975     History of Changes
Other Study ID Numbers: 03-109
Study First Received: November 22, 2006
Last Updated: February 21, 2014
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 July 24, 2014