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Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

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ClinicalTrials.gov Identifier: NCT03971357
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Brief Summary:
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.

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Netarsudil
netarsudil opthalmic solution 0.02%
Other Name: Rhopressa

Placebo Comparator: 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.
Drug: Placebo
Placebo eye drops




Primary Outcome Measures :
  1. Rate of corneal clearing after endothelial removal for treatment of Fuchs dystrophy [ Time Frame: 6 weeks ]
    Area of cornea that has not cleared as a proportion of the area stripped of endothelium


Secondary Outcome Measures :
  1. Time to complete corneal clearing [ Time Frame: 3 months ]
    Number of days from endothelial removal to complete corneal clearing

  2. Central endothelial cell density [ Time Frame: 3 months ]
    Central corneal endothelial cell density assessed with specular microscopy

  3. Time to reach corrected distance visual acuity of 20/40 or better [ Time Frame: 3 months ]
    Number of days from endothelial removal to recovery of corrected distance visual acuity of 20/40 or better



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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:

  • 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.

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): NCT03971357


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: Francis W Price, Jr., MD         
Principal Investigator: Francis W Price, Jr., MD         
Sponsors and Collaborators
Price Vision Group
Investigators
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Principal Investigator: Francis W Price, Jr, MD Price Vision Group

Publications:
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Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT03971357     History of Changes
Other Study ID Numbers: 2018-009
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 8, 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 Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn