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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2019-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

NCT03971357

Fuchs' Endothelial Dystrophy

TERMINATED PHASE2/PHASE3

Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

NCT04057053

Fuchs' Endothelial Dystrophy Cataract

COMPLETED EARLY_PHASE1

Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment

NCT06033703

Rhegmatogenous Retinal Detachment Proliferative Vitreoretinopathy

RECRUITING PHASE1/PHASE2

Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

NCT04051463

Fuchs Endothelial Dystrophy

COMPLETED PHASE2/PHASE3

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

NCT04498169

Corneal Edema

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fuchs' Endothelial Dystrophy Bullous Keratopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Netarsudil

Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months

Group Type EXPERIMENTAL

Netarsudil

Intervention Type DRUG

netarsudil opthalmic solution 0.02%

Placebo

Placebo eye drop, dosed topically once a day for 9 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo eye drops

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Netarsudil

netarsudil opthalmic solution 0.02%

Intervention Type DRUG

Placebo

Placebo eye drops

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No