Ocular HypertensionPhase 1/2NCT04761705
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing JV-GL1 and Latanoprost 0.005% Ophthalmic Solution in people with Ocular Hypertension and Open Angle Glaucoma, run by JeniVision, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- JV-GL1 and Latanoprost 0.005% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral open-angle glaucoma or ocular hypertension
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
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
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.
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- JV-GL1, Latanoprost 0.005% Ophthalmic Solution
- Keywords
- open angle glaucoma, Ocular Hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JV-GL1Drug
Experimental Treatment
Latanoprost 0.005% Ophthalmic SolutionDrug
Active Control
| Study group | Role | What they receive |
|---|---|---|
| Randomized Part 2, Arm 1 | Experimental | Dose 1 selected in Part I Receives: Drug: JV-GL1 |
| Randomized Part 2, Arm 2 | Experimental | Dose 2 selected in Part I Receives: Drug: JV-GL1 |
| Randomized Part 2, Arm 3 | Active comparator | Not described Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Change from baseline in Intraocular Pressure (IOP)
Measured: From Baseline to Day 28 of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Mar 2021
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Awaiting transition to Part 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JeniVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wirta, MD, Principal investigator, Eye Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761705
- Sponsor's protocol ID
- JV-GL1-OCU-GL-101/201-01
- Status last verified
- May 2024
- First submitted
- 16 Feb 2021
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04761705
- Acronym / sponsor ID
- JV-GL1-OCU-GL-101/201-01
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- open angle glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting transition to Part 2
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- JeniVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Part 2, Arm 1 | Experimental | Drug: JV-GL1Dose 1 selected in Part I |
| Randomized Part 2, Arm 2 | Experimental | Drug: JV-GL1Dose 2 selected in Part I |
| Randomized Part 2, Arm 3 | Active comparator | Drug: Latanoprost 0.005% Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral open-angle glaucoma or ocular hypertension
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JV-GL1Experimental Treatment | Drug | Randomized Part 2, Arm 1, Randomized Part 2, Arm 2 |
| Latanoprost 0.005% Ophthalmic SolutionActive Control | Drug | Randomized Part 2, Arm 3 |
Primary outcome
Intraocular Pressure (IOP)
Time frame: From Baseline to Day 28 of Treatment
Change from baseline in Intraocular Pressure (IOP)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wirta, MD principal investigator
Eye Research Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JV-GL1 and Latanoprost 0.005% Ophthalmic Solution in people with Ocular Hypertension and Open Angle Glaucoma, run by JeniVision, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: From Baseline to Day 28 of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.