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

April 12, 2020 updated by: Richard Trevino, OD, FAAO, University of the Incarnate Word
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • University of the Incarnate Word

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripapillary capillary perfusion density
Time Frame: 90 minutes
Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular capillary perfusion density
Time Frame: 90 minutes
Mean change in macular capillary perfusion as assessed using optical coherence tomography angiography
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Incarnate Word

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (ACTUAL)

January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-12-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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