Back to resultsRhopressa for Corneal Edema Associated With Fuchs Dystrophy
Primary Purpose
Fuchs Endothelial Dystrophy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Netarsudil Ophthalmic Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs Endothelial Dystrophy
Eligibility Criteria
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.
Sites / Locations
- Price Vision Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Netarsudil
Placebo
Arm Description
A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
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.
Outcomes
Primary Outcome Measures
Change in Central Corneal Thickness
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
Secondary Outcome Measures
Change in Corrected Distance Visual Acuity (CDVA)
Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04051463
Brief Title
Rhopressa for Corneal Edema Associated With Fuchs Dystrophy
Official Title
Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs Endothelial Dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Netarsudil
Arm Type
Active Comparator
Arm Description
A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic Solution
Other Intervention Name(s)
Rhopressa
Intervention Description
Netarsudil eye drops instilled once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Rhopressa vehicle without active ingredient
Intervention Description
Placebo eye drops instilled once daily
Primary Outcome Measure Information:
Title
Change in Central Corneal Thickness
Description
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in Corrected Distance Visual Acuity (CDVA)
Description
Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr, MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33737034
Citation
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.
Results Reference
result
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Rhopressa for Corneal Edema Associated With Fuchs Dystrophy
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