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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

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03971357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Time to complete corneal clearing [ Time Frame: 3 months ]
    Number of days from endothelial removal to complete corneal clearing
  • Central endothelial cell density [ Time Frame: 3 months ]
    Central corneal endothelial cell density assessed with specular microscopy
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
Official Title  ICMJE Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fuchs' Endothelial Dystrophy
Intervention  ICMJE
  • Drug: Netarsudil
    netarsudil opthalmic solution 0.02%
    Other Name: Rhopressa
  • Drug: Placebo
    Placebo eye drops
Study Arms  ICMJE
  • 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
    Intervention: Drug: Netarsudil
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marianne O Price, PhD 317-814-2990 mprice@cornea.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971357
Other Study ID Numbers  ICMJE 2018-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Price Vision Group
Study Sponsor  ICMJE Price Vision Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis W Price, Jr, MD Price Vision Group
PRS Account Price Vision Group
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP