Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

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 Presbyopia

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 Presbyopia.

Inclusion Criteria:

• Presbyopic male or female 40-55 years of age
• Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

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
• History of, or active, iritis or uveitis in either eye
• Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment