The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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