Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Price Vision Group
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
Study Overview
Brief Summary
Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
Detailed Description
Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
- •Is able and willing to administer eye drops
- •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.
Arms & Interventions
Netarsudil
Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner
Intervention: Netarsudil (Drug)
Placebo
Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
Time Frame: 5 weeks
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
Secondary Outcomes
No secondary outcomes reported