Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor
JeniVision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04761705
Collaborator
(none)
70
1
3
27.7
2.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Mar 10, 2021
Anticipated Primary Completion Date
:
Mar 1, 2023
Anticipated Study Completion Date
:
Jul 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Randomized Part 2, Arm 1 Dose 1 selected in Part I |
Drug: JV-GL1
Experimental Treatment
|
| Experimental: Randomized Part 2, Arm 2 Dose 2 selected in Part I |
Drug: JV-GL1
Experimental Treatment
|
| Active Comparator: Randomized Part 2, Arm 3
|
Drug: Latanoprost 0.005% Ophthalmic Solution
Active Control
|
Outcome Measures
Primary Outcome Measures
- Intraocular Pressure (IOP) [From Baseline to Day 28 of Treatment]
Change from baseline in Intraocular Pressure (IOP)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- bilateral open-angle glaucoma or ocular hypertension
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye Research Foundation | Newport Beach | California | United States | 92663 |
Sponsors and Collaborators
- JeniVision, Inc.
Investigators
- Principal Investigator: David Wirta, MD, Eye Research Foundation, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JeniVision, Inc.
ClinicalTrials.gov Identifier:
NCT04761705
Other Study ID Numbers:
- JV-GL1-OCU-GL-101/201-01
First Posted:
Feb 21, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by JeniVision, Inc.
Additional relevant MeSH terms: