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

Completed · Phase 2 · Has a placebo group

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT05124275

Run by

Glaukos Corporation

People needed

123

Starts

2022-01-03

Expected to finish

2022-09-06

Last updated by the study team

2023-09-01

Who can join

Age: 40 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Glaukos Investigator — Chandler, Arizona, United States
• Glaukos Investigator — Sun City, Arizona, United States
• Glaukos Investigator — Glendale, California, United States
• Glaukos Investigator — Newport Beach, California, United States
• Glaukos Investigator — Petaluma, California, United States
• Glaukos Investigator — Louisville, Kentucky, United States
• Glaukos Investigator — Rochester, New York, United States
• Glaukos Investigator — Memphis, Tennessee, United States
• Glaukos Investigator — Houston, Texas, United States
• Glaukos Investigator — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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