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
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 April 15, 2014