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



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:September 5, 2017
End Date:September 2019

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Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation

Cornea transplant recipients who are using topical corticosteroids long-term to prevent
transplant rejection will be randomized to use netarsudil or placebo.


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 IOP > 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.
We found this trial at
1
site
Indianapolis, Indiana 46260
Principal Investigator: Francis W Price, Jr., MD
Phone: 317-814-2990
?
mi
from
Indianapolis, IN
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