Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.

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

Details

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

Criteria

Inclusion Criteria:

• Provide written informed consent prior to any study procedures being performed.

• Have a best corrected visual acuity (BCVAof +0.7 or better.

• Have a history of dry eye (keratoconjunctivitis sicca) in both eyes

• Have ongoing dry eye disease, in the same qualifying eye or both eyes.

Exclusion Criteria:

• Have previously had LASIK refractive surgery.

• Use of topical ophthalmic medications, preps, gels and lid scrubs during study.

• Have had penetrating intraocular surgery in the past 90 days.

• Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.

• Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.

• Any serious ocular systemic disease or uncontrolled medical condition.

• Exposure to any investigational drug within 30 days of study start.