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
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.
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 November 25, 2014
Dry Eye Syndromes
Lacrimal Apparatus Diseases