Fuchs' Endothelial Dystrophy, Bullous Keratopathy
Conditions
Brief summary
Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
Interventions
DRUGNetarsudil
netarsudil opthalmic solution 0.02%
DRUGPlacebo
Placebo eye drops
Sponsors
Cornea Research Foundation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 undergoing Descemet membrane endothelial keratoplasty; patient is able and willing to administer eye drops; patient is able to comprehend and has signed the Informed Consent form; patient is likely to complete the nine-month course of the study.
Exclusion criteria
* A patient exhibiting pre-operative intraocular inflammation; a patient with a known sensitivity to any of the ingredients in the study medications; a patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study; a patient with abnormal eyelid function; a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis; a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or trabeculectomy, or with preoperative intraocular pressure \> 22 mm Hg in the potential study eye; presence of any ocular disease that would interfere with the evaluation of the study treatment (however, patients with a history of cystoid macular edema, age-related macular degeneration, corneal neovascularization, and other non-interfering comorbidities may be enrolled); a patient with a history of non-compliance with using prescribed medication; a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study; patients who are pregnant or planning to become pregnant within the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months | Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading. |
Countries
United States
Participant flow
Recruitment details
As specified in the protocol, a total of 120 unique participants were enrolled in the study; 71 enrolled both eyes in the study and the fellow eyes were automatically assigned to opposite treatment arms, so 71 subjects participated in both treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
Netarsudil: netarsudil opthalmic solution 0.02% | 95 |
| Placebo Placebo eye drop, dosed topically once a day for 9 months
Placebo: Placebo eye drops | 96 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | Placebo | Total | Netarsudil |
|---|---|---|---|
| Age, Continuous | 67 years | 67 years | 68 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 96 Participants | 191 Participants | 95 Participants |
| Sex: Female, Male Female | 61 Participants | 115 Participants | 54 Participants |
| Sex: Female, Male Male | 35 Participants | 76 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 96 |
| other Total, other adverse events | 31 / 95 | 18 / 96 |
| serious Total, serious adverse events | 0 / 95 | 0 / 96 |
Outcome results
Primary
Intraocular Pressure
Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.
Time frame: from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Netarsudil | Intraocular Pressure | 11 Participants |
| Placebo | Intraocular Pressure | 18 Participants |