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Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

NCT ID: NCT04051463

Last Updated: 2021-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-07-01

Brief Summary

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The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.

Detailed Description

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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
The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.

Study Groups

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Netarsudil

A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.

Group Type ACTIVE_COMPARATOR

Netarsudil Ophthalmic Solution

Intervention Type DRUG

Netarsudil eye drops instilled once daily

Placebo

A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo eye drops instilled once daily

Interventions

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Netarsudil Ophthalmic Solution

Netarsudil eye drops instilled once daily

Intervention Type DRUG

Placebo

Placebo eye drops instilled once daily

Intervention Type DRUG

Other Intervention Names

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Rhopressa Rhopressa vehicle without active ingredient

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
* Patient is able and willing to administer eye drops.
* Patient 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

Sponsors

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Price Vision Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis W Price, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

Locations

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Price Vision Group

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.

Reference Type RESULT
PMID: 33737034 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019-007

Identifier Type: -

Identifier Source: org_study_id