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

Last updated: May 8, 2024
Sponsor: JeniVision, Inc.
Overall Status: Suspended

Phase

1/2

Condition

Williams Syndrome

Glaucoma

Stress

Treatment

JV-GL1

Latanoprost 0.005% Ophthalmic Solution

Clinical Study ID

NCT04761705
JV-GL1-OCU-GL-101/201-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • bilateral open-angle glaucoma or ocular hypertension

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: JV-GL1
Phase: 1/2
Study Start date:
March 10, 2021
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

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