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

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ClinicalTrials.gov Identifier: NCT03248037
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : January 26, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier (NCT number): NCT03248037


Contacts
Contact: Marianne O Price, PhD 317-814-2990 mprice@cornea.org

Locations
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Marianne Price, PhD    317-814-2990    mprice@cornea.org   
Principal Investigator: Francis W Price, Jr., MD         
Sub-Investigator: Matthew T Feng, MD         
Sponsors and Collaborators
Cornea Research Foundation of America
Investigators
Principal Investigator: Francis W Price, Jr, MD Price Vision Group

Publications:
Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT03248037     History of Changes
Other Study ID Numbers: 2017-003
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn