Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Fuchs Endothelial Dystrophy Clinical Trial

Official title:

Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051463
• Other study ID #: 2019-007
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 5, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2021
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Netarsudil Ophthalmic Solution
Netarsudil eye drops instilled once daily
• Placebo
Placebo eye drops instilled once daily

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Central Corneal Thickness	Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline	1 month
Secondary	Change in Corrected Distance Visual Acuity (CDVA)	Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)	3 months