Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

• Status: Terminated
• Trial end date: 2021-08-26
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

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

Details

• Lead Sponsor: Cornea Research Foundation of America; Price Vision Group

Criteria

Inclusion Criteria:

• Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy

• Is able and willing to administer eye drops

• 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.