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

Primary Purpose

Glaucoma, Open-Angle

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Netarsudil Ophthalmic
Sponsored by
University of the Incarnate Word
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of the Incarnate WordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Netarsudil alone

Netarsudil plus latanoprost

Arm Description

Topical application of netarsudil 0.02%

Topical application of netarsudil 0.02% with latanoprost 0.005%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2020
Last Updated
April 12, 2020
Sponsor
University of the Incarnate Word
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1. Study Identification

Unique Protocol Identification Number
NCT04234932
Brief Title
Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Official Title
Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil alone
Arm Type
Experimental
Arm Description
Topical application of netarsudil 0.02%
Arm Title
Netarsudil plus latanoprost
Arm Type
Active Comparator
Arm Description
Topical application of netarsudil 0.02% with latanoprost 0.005%
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic
Other Intervention Name(s)
Latanoprost Ophthalmic
Intervention Description
Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)
Primary Outcome Measure Information:
Title
Peripapillary capillary perfusion density
Description
Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Macular capillary perfusion density
Description
Mean change in macular capillary perfusion as assessed using optical coherence tomography angiography
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Jo Bilicek
Phone
210-805-3565
Email
bilicek@uiwtx.edu
Facility Information:
Facility Name
University of the Incarnate Word
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana C Hagendorf, PhD
Phone
210-805-3036
Email
wandless@uiwtx.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared

Learn more about this trial

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

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