Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

September 23, 2021 updated by: Price Vision Group

Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Netarsudil
A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
Drug: Netarsudil Ophthalmic Solution
Netarsudil eye drops instilled once daily
Other Names:
  • Rhopressa
Placebo Comparator: Placebo
A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.
Drug: Placebo
Placebo eye drops instilled once daily
Other Names:
  • Rhopressa vehicle without active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Central Corneal Thickness
Time Frame: 1 month
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Price Vision Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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