Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease

This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of Dry Eye Disease.

Inclusion Criteria:

• Male or female, 18 years of age or older at the Screening Visit
• Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
• Diagnosis of dry eye

Exclusion Criteria:

• Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
• History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
• History of, or active iritis or uveitis in either eye
• Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment