Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: November 22, 2006
Last updated: November 25, 2014
Last verified: November 2014
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.
Dry Eye Disease
Drug: diquafosol tetrasodium ophthalmic solution, 2%
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Change in dry eye testing measures
Secondary Outcome Measures:
- Change in dry eye testing measures and symptoms
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- permanent conjunctival goblet cell loss or scarring conditions
- ongoing contact lens wear
- current topical ophthalmic medication use
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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 22, 2006
||November 25, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015