Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2021-08-26

Brief Summary

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Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

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Detailed Description

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Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.

Conditions

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Fuchs' Endothelial Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Netarsudil

Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner

Group Type EXPERIMENTAL

Netarsudil

Intervention Type DRUG

netarsudil opthalmic solution 0.02%

Placebo

Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo eye drops

Interventions

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Netarsudil

netarsudil opthalmic solution 0.02%

Intervention Type DRUG

Placebo

Placebo eye drops

Intervention Type DRUG

Other Intervention Names

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Rhopressa

Eligibility Criteria

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Inclusion Criteria

* Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
* Is able and willing to administer eye drops
* Is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria

* Active intraocular inflammation
* Corneal ulceration, keratitis, or conjunctivitis
* Known sensitivity to any of the ingredients in the study medications
* Abnormal eyelid function
* History of herpetic keratitis
* History of non-compliance with using prescribed medication
* Current or planned pregnancy within the study duration
* Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
* Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No