Back to resultsSafety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension, Open Angle Glaucoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JV-GL1
Latanoprost 0.005% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring open angle glaucoma, Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- bilateral open-angle glaucoma or ocular hypertension
Exclusion Criteria:
-
Sites / Locations
- Eye Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Randomized Part 2, Arm 1
Randomized Part 2, Arm 2
Randomized Part 2, Arm 3
Arm Description
Dose 1 selected in Part I
Dose 2 selected in Part I
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
Change from baseline in Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04761705
Brief Title
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JeniVision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma
Keywords
open angle glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Randomized Part 2, Arm 1
Arm Type
Experimental
Arm Description
Dose 1 selected in Part I
Arm Title
Randomized Part 2, Arm 2
Arm Type
Experimental
Arm Description
Dose 2 selected in Part I
Arm Title
Randomized Part 2, Arm 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
JV-GL1
Intervention Description
Experimental Treatment
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% Ophthalmic Solution
Intervention Description
Active Control
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Change from baseline in Intraocular Pressure (IOP)
Time Frame
From Baseline to Day 28 of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bilateral open-angle glaucoma or ocular hypertension
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wirta, MD
Organizational Affiliation
Eye Research Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
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