Back to resultsStudy of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diquafosol tetrasodium ophthalmic solution, 2%
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in dry eye testing measures
Secondary Outcome Measures
Change in dry eye testing measures and symptoms
Full Information
NCT ID
NCT00403975
First Posted
November 22, 2006
Last Updated
February 19, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00403975
Brief Title
Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
640 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
diquafosol tetrasodium ophthalmic solution, 2%
Primary Outcome Measure Information:
Title
Change in dry eye testing measures
Secondary Outcome Measure Information:
Title
Change in dry eye testing measures and symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
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