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

Phase 1

Suspended

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: JV-GL1

• Registration Number: NCT04761705
• Lead Sponsor: JeniVision, Inc.

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Study Start: 2021-03-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Part 2, Arm 3	Latanoprost 0.005% Ophthalmic Solution	-
Randomized Part 2, Arm 2	JV-GL1	Dose 2 selected in Part I
Randomized Part 2, Arm 1	JV-GL1	Dose 1 selected in Part I

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	From Baseline to Day 28 of Treatment	Change from baseline in Intraocular Pressure (IOP)

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States