Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT04761705

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts:

Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1.

Part 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost for 28 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Hypertension Open Angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomized Part 2, Arm 1

Dose 1 selected in Part I

Group Type EXPERIMENTAL

JV-GL1

Intervention Type DRUG

Experimental Treatment

Randomized Part 2, Arm 2

Dose 2 selected in Part I

Group Type EXPERIMENTAL

JV-GL1

Intervention Type DRUG

Experimental Treatment

Randomized Part 2, Arm 3

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Active Control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JV-GL1

Experimental Treatment

Intervention Type DRUG

Latanoprost 0.005% Ophthalmic Solution

Active Control

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

JeniVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Wirta, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Research Foundation, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye Research Foundation

Newport Beach, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JV-GL1-OCU-GL-101/201-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.