Fuchs Endothelial Dystrophy
Conditions
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.
Interventions
DRUGNetarsudil Ophthalmic Solution
Netarsudil eye drops instilled once daily
DRUGPlacebo
Placebo eye drops instilled once daily
Sponsors
Price Vision Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Corneal Thickness | 1 month | Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corrected Distance Visual Acuity (CDVA) | 3 months | Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Netarsudil A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily | 15 |
| 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: Placebo eye drops instilled once daily | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Placebo | Total | Netarsudil |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 7 | 68 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized White, non-Hispanic | 14 Participants | 29 Participants | 15 Participants |
| Region of Enrollment United States | 14 participants | 29 participants | 15 participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 6 / 15 | 3 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
Change in Central Corneal Thickness
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Netarsudil | Change in Central Corneal Thickness | -23 microns |
| Placebo | Change in Central Corneal Thickness | -2 microns |
Secondary
Change in Corrected Distance Visual Acuity (CDVA)
Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Netarsudil | Change in Corrected Distance Visual Acuity (CDVA) | 1.9 lines on the eye chart |
| Placebo | Change in Corrected Distance Visual Acuity (CDVA) | 0.3 lines on the eye chart |