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Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation

Sponsor
University of the Incarnate Word (Other)
Overall Status
Unknown status
CT.gov ID
NCT04234932
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
11.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution.

Condition or Disease Intervention/Treatment Phase
  • Drug: Netarsudil Ophthalmic
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Netarsudil alone

Topical application of netarsudil 0.02%

Drug: Netarsudil Ophthalmic
Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)
Other Names:
  • Latanoprost Ophthalmic

    		•
    Active Comparator: Netarsudil plus latanoprost

    Topical application of netarsudil 0.02% with latanoprost 0.005%

    Drug: Netarsudil Ophthalmic
    Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)
    Other Names:
  • Latanoprost Ophthalmic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peripapillary capillary perfusion density [90 minutes]

      Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography

    Secondary Outcome Measures

    1. Macular capillary perfusion density [90 minutes]

      Mean change in macular capillary perfusion as assessed using optical coherence tomography angiography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal ocular health
    Exclusion Criteria:

    • Females who are or may be pregnant or who are nursing

    • Uncontrolled hypertension

    • Allergy to netarsudil or latanoprost

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of the Incarnate Word San Antonio Texas United States 78209

    Sponsors and Collaborators

    • University of the Incarnate Word

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Trevino, OD, FAAO, Principal Investigator, University of the Incarnate Word
    ClinicalTrials.gov Identifier:
    NCT04234932
    Other Study ID Numbers:
    • 19-12-005
    First Posted:
    Jan 21, 2020
    Last Update Posted:
    Apr 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Latanoprost

    Study Results

    No Results Posted as of Apr 14, 2020