NCT04761705

Brief Summary

The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

February 16, 2021

Last Update Submit

May 8, 2024

Conditions

Ocular HypertensionOpen Angle Glaucoma

Keywords

open angle glaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    Change from baseline in Intraocular Pressure (IOP)

    From Baseline to Day 28 of Treatment

Study Arms (3)

Randomized Part 2, Arm 1

EXPERIMENTAL

Dose 1 selected in Part I

Drug: JV-GL1

Randomized Part 2, Arm 2

EXPERIMENTAL

Dose 2 selected in Part I

Drug: JV-GL1

Randomized Part 2, Arm 3

ACTIVE COMPARATOR
Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

JV-GL1DRUG

Experimental Treatment

Randomized Part 2, Arm 1Randomized Part 2, Arm 2
Latanoprost 0.005% Ophthalmic SolutionDRUG

Active Control

Randomized Part 2, Arm 3

Eligibility Criteria

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

You may qualify if:

  • bilateral open-angle glaucoma or ocular hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

LatanoprostOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • David Wirta, MD

    Eye Research Foundation, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

March 10, 2021

Primary Completion

March 1, 2025

Study Completion

July 1, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

US(1)