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NCT04761705 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
A Phase 1/2 Safety and Efficacy Study of JV-GL1 Applied to the Periorbital Skin in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04761705
Other study ID # JV-GL1-OCU-GL-101/201-01
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date March 10, 2021
Est. completion date July 2025

Study information
Verified date May 2024
Source JeniVision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 70
Est. completion date July 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - bilateral open-angle glaucoma or ocular hypertension Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JV-GL1
Experimental Treatment
• Latanoprost 0.005% Ophthalmic Solution
Active Control

Locations
Country Name City State
United States Eye Research Foundation Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
JeniVision, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) Change from baseline in Intraocular Pressure (IOP) From Baseline to Day 28 of Treatment
See also
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