NCT04234932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

January 15, 2020

Last Update Submit

April 12, 2020

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Peripapillary capillary perfusion density

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

    90 minutes

Secondary Outcomes (1)

  • Macular capillary perfusion density

    90 minutes

Study Arms (2)

Netarsudil alone

EXPERIMENTAL

Topical application of netarsudil 0.02%

Drug: Netarsudil Ophthalmic

Netarsudil plus latanoprost

ACTIVE COMPARATOR

Topical application of netarsudil 0.02% with latanoprost 0.005%

Drug: Netarsudil Ophthalmic

Interventions

Netarsudil OphthalmicDRUG

Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)

Also known as: Latanoprost Ophthalmic
Netarsudil aloneNetarsudil plus latanoprost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal ocular health

You may not qualify if:

  • Females who are or may be pregnant or who are nursing
  • Uncontrolled hypertension
  • Allergy to netarsudil or latanoprost

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Incarnate Word

San Antonio, Texas, 78209, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Mary Jo Bilicek

CONTACT

210-805-3565bilicek@uiwtx.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 21, 2020

Study Start

January 6, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared

Locations

US(1)