Phase 3
N=191
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Fuchs' Endothelial Dystrophy · Bullous Keratopathy
Bottom Line
View on ClinicalTrials.gov: NCT03248037 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Intraocular Pressure — 11; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Netarsudil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cornea Research Foundation of America
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
11; 18 | — |
Summary
Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03248037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.