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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403975
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Disease Drug: diquafosol tetrasodium ophthalmic solution, 2% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Primary Outcome Measures :
  1. Change in dry eye testing measures

Secondary Outcome Measures :
  1. Change in dry eye testing measures and symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00403975    
Other Study ID Numbers: 03-109
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions