Overview

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.