Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream (4%, 6%, 8%)

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream 4%, 6%, and 8% BID for the Treatment of Signs and Symptoms of Dry Eye Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaukos Corporation
• Treatments: Pilocarpine

Criteria

Inclusion Criteria:

• 1. Male or female, 18 years of age or older at the Screening Visit

• 2. Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form

• 3. Diagnosis of dry eye

Exclusion Criteria:

• 1. Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation

• 2. History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.

• 3. History of, or active iritis or uveitis in either eye

• 4. Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment