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

Phase 3

Completed

• Conditions: Fuchs' Endothelial Dystrophy; Bullous Keratopathy
• Interventions: Drug: Netarsudil; Drug: Placebo

• Registration Number: NCT03248037
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Study Start: 2017-09-05
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Status Verified: 2021-01
• Results First Submitted: 2021-01-25
• Results First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Results First Posted: 2021-02-12
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil	Netarsudil	Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
Placebo	Placebo	Placebo eye drop, dosed topically once a day for 9 months

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months	Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States