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

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

Status
Suspended
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761705
Enrollment
70
Registered
2021-02-21
Start date
2021-03-10
Completion date
2025-07-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

open angle glaucoma, Ocular Hypertension

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.

Interventions

DRUGJV-GL1

Experimental Treatment

Sponsors

JeniVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* bilateral open-angle glaucoma or ocular hypertension

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure (IOP)From Baseline to Day 28 of TreatmentChange from baseline in Intraocular Pressure (IOP)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026