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

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 pastyear.

• 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.