Status:
COMPLETED
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.
Eligibility Criteria
Inclusion
- Have best corrected visual acuity in both eyes of at least +0.7 or better
- Central corneal staining of 3 on the NEI scale
- If female, are non-pregnant or non-lactating
- Have a history of dry eye disease in both eyes
- Have normal lid anatomy
Exclusion
- Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
- Have had ocular surface surgery within the past year
- Are considered legally blind in one eye
- Have a serious medical condition which could confound study assessments
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00831662
Start Date
January 1 2009
End Date
December 1 2009
Last Update
January 9 2015
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