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SuspendedNCT04761705Updated May 10, 2024

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

A Phase 1/2 interventional study of JV-GL1 and Latanoprost 0.005% Ophthalmic Solution in Ocular Hypertension and Open Angle Glaucoma, sponsored by JeniVision, Inc.. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by JeniVision, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was suspended
Awaiting transition to Part 2
Phase
Phase 1/2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Ocular Hypertension
  • Open Angle Glaucoma

Keywords

  • open angle glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 70 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with JeniVision, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bilateral open-angle glaucoma or ocular hypertension

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Randomized Part 2, Arm 1

    Dose 1 selected in Part I

    Drug: JV-GL1

  • Experimental
    Randomized Part 2, Arm 2

    Dose 2 selected in Part I

    Drug: JV-GL1

  • Active comparator
    Randomized Part 2, Arm 3

    Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

  • DrugJV-GL1

    Experimental Treatment

  • DrugLatanoprost 0.005% Ophthalmic Solution

    Active Control

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure (IOP)

    Change from baseline in Intraocular Pressure (IOP)

    Time frame: From Baseline to Day 28 of Treatment

07

Study locations

1 site
  • Eye Research Foundation
    Newport Beach, California 92663, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04761705
Lead sponsor
JeniVision, Inc.
Responsible party
Sponsor
First posted
Feb 21, 2021
Start date
Mar 10, 2021
Primary completion
Mar 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
May 10, 2024

Study contacts

David Wirta, MD
principal investigator · Eye Research Foundation, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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