COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03248037
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : July 12, 2019
Information provided by (Responsible Party):
Cornea Research Foundation of America

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

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Bullous Keratopathy Drug: Netarsudil Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : July 9, 2019
Actual Study Completion Date : July 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Netarsudil

Arm Intervention/treatment
Experimental: Netarsudil
Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
Drug: Netarsudil
netarsudil opthalmic solution 0.02%

Placebo Comparator: Placebo
Placebo eye drop, dosed topically once a day for 9 months
Drug: Placebo
Placebo eye drops

Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: from date of randomization until the date of first documented intraocular pressure elevation up to 9 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03248037

Layout table for location information
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Cornea Research Foundation of America
Layout table for investigator information
Principal Investigator: Francis W Price, Jr, MD Price Vision Group
Layout table for additonal information
Responsible Party: Cornea Research Foundation of America Identifier: NCT03248037    
Other Study ID Numbers: 2017-003
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn