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

A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease

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

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.