Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Price Vision Group
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• At least 18 years of age

• Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.

• Patient is able and willing to administer eye drops.

• Patient is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

• Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.

• Known sensitivity to any of the ingredients in the study medications.

• Abnormal eyelid function.

• History of herpetic keratitis.

• History of non-compliance with using prescribed medication.

• Current or planned pregnancy within the study duration.

• Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.

• Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.