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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease, Kerato Conjunctivitis Sicca

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 Signs and Symptoms of Dry Eye Disease.

Key facts

Study ID

NCT05119920

Run by

Glaukos Corporation

People needed

226

Starts

2022-01-03

Expected to finish

2022-07-27

Last updated by the study team

2023-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 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

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 — Mission Hills, California, United States
• Glaukos Investigator — Newport Beach, California, United States
• Glaukos Investigator — Petaluma, California, United States
• Glaukos Investigator — Rancho Cordova, California, United States
• Glaukos Investigator — Grand Junction, Colorado, United States
• Glaukos Investigator — Fort Myers, Florida, United States
• Glaukos Investigator — Roswell, Georgia, United States
• Glaukos Investigator — St Louis, Missouri, United States
• Glaukos Investigator — Henderson, Nevada, United States
• Glaukos Investigator — Rochester, New York, United States
• Glaukos Investigator — Cranberry Township, Pennsylvania, United States
• Glaukos Investigator — Memphis, Tennessee, United States
• Glaukos Investigator — Nashville, Tennessee, United States
• Glaukos Investigator — Houston, Texas, United States
• Glaukos Investigator — San Antonio, Texas, United States
• Glaukos Investigator — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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