Skip to main content
OpenTrials
Completed

NCT Number: NCT04051463

Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fuchs Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Netarsudil Ophthalmic Solution

Drug

Netarsudil eye drops instilled once daily

Other names: Rhopressa

Placebo

Drug

Placebo eye drops instilled once daily

Other names: Rhopressa vehicle without active ingredient

Primary outcomes

  1. Change in Central Corneal Thickness

    Time frame: 1 month

    Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline

Secondary outcomes

  1. Change in Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months

    Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)

Sponsors and collaborators

Lead sponsor

Price Vision Group

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.