- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051463
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
-
-
Indiana
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Indianapolis, Indiana, United States, 46260
- Price Vision Group
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-
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.
|
Netarsudil eye drops instilled once daily
Other Names:
|
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.
|
Placebo eye drops instilled once daily
Other Names:
|
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
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.
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.
Clinical Trials on Fuchs Endothelial Dystrophy
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Kowa Research Institute, Inc.CompletedFuchs' Endothelial Corneal DystrophyUnited States, Australia, Germany, Spain, Denmark
-
Legacy Health SystemDevers Eye Institute; Lions Eye Bank of Oregon Vision Research Laboratory; Fischer...UnknownFuchs' Corneal Endothelial DystrophyUnited States
-
Massachusetts Eye and Ear InfirmaryRecruitingFuchs' Endothelial Corneal DystrophyUnited States
-
State University of New York at BuffaloActive, not recruitingFuchs DystrophyUnited States
-
EmmecellRecruitingEndothelial Dysfunction | Corneal Edema | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Bullous Keratopathy | Pseudophakic Bullous Keratopathy | Corneal Endothelial Dysfunction | Fuchs Endothelial Corneal Dystrophy | Moderate Corneal Endothelial DecompensationUnited States
-
Charite University, Berlin, GermanyUnknownEndothelial Dysfunction | Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyGermany
-
Cornea Research Foundation of AmericaCompletedBullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyUnited States
-
Trefoil Therapeutics, Inc.CompletedEndothelial Dysfunction | Corneal Endothelial Dystrophy | Pseudophakic Bullous Keratopathy | Fuchs Endothelial Corneal DystrophyUnited States
-
Centre Hospitalier Universitaire de Saint EtienneKyoto University, Graduate School of MedicineCompletedFuchs Endothelial Corneal DystrophyFrance
-
Centre Hospitalier Régional Metz-ThionvilleCompletedPseudophakic Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Descemet Membrane Endothelial Keratoplasty | Graft DetachmentFrance
Clinical Trials on Netarsudil Ophthalmic Solution
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open Angle GlaucomaJapan
-
Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma | Ocular HypertensionJapan
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open Angle GlaucomaUnited States
-
Aerie PharmaceuticalsCompletedHealthy SubjectsUnited States
-
Massachusetts Eye and Ear InfirmaryCompletedCataract | Fuchs' Endothelial DystrophyUnited States
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Glaucoma, Open-AngleUnited States
-
Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma or Ocular HypertensionUnited States
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open Angle GlaucomaUnited States
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open Angle GlaucomaUnited States
-
Aerie PharmaceuticalsCompletedOcular Hypertension | Open-angle GlaucomaUnited States