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Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

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ClinicalTrials.gov Identifier: NCT04051463
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fuchs Endothelial Dystrophy Drug: Netarsudil Ophthalmic Solution Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : November 5, 2020
Estimated Study Completion Date : December 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Netarsudil
A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
Drug: Netarsudil Ophthalmic Solution
Netarsudil eye drops instilled once daily
Other Name: Rhopressa

Placebo Comparator: 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.
Drug: Placebo
Placebo eye drops instilled once daily
Other Name: Rhopressa vehicle without active ingredient




Primary Outcome Measures :
  1. Central corneal thickness [ Time Frame: 1 month ]
    Central corneal thickness


Secondary Outcome Measures :
  1. Corrected distance visual acuity [ Time Frame: 3 months ]
    Corrected distance visual acuity



Information from the National Library of Medicine

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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 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.

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): NCT04051463


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

Locations
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United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Marianne Price, Ph.D    317-814-2990    marianneprice@cornea.org   
Principal Investigator: Francis W Price, MD         
Sponsors and Collaborators
Price Vision Group
Investigators
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Principal Investigator: Francis W Price, Jr, MD Price Vision Group

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Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT04051463     History of Changes
Other Study ID Numbers: 2019-007
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Edema
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Ophthalmic Solutions
Pharmaceutical Solutions