Overview

Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation

Status:
Completed
Trial end date:
2019-07-09
Target enrollment:
0
Participant gender:
All
Summary
Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cornea Research Foundation of America
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.