CompletedInterventionalPhase 3Updated Nov 29, 2016
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637) | NCT00831662 | Trialant
CompletedInterventionalPhase 3Updated Jan 9, 2015
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
ClinicalTrials.gov ID
NCT00831662
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
490Actual
Last Update Posted
Jan 9, 2015Estimated
Start Date
Jan 2009
Primary Completion Date
Dec 2009Actual
Completion Date
Dec 2009Actual
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.
Dry Eye Disease
Diquafosol tetrasodium ophthalmic solution, 2%
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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