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

Overseen By David Wirta, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: JeniVision, Inc.

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the purpose of this trial?

This trial is testing a new drug called JV-GL1 to see if it can safely lower eye pressure in adults with open-angle glaucoma or ocular hypertension. By reducing eye pressure, JV-GL1 might help protect vision.

Research Team

David Wirta, MD

Principal Investigator

Eye Research Foundation, Inc.

Eligibility Criteria

Inclusion Criteria

You have glaucoma or ocular hypertension.

Exclusion Criteria

I am sorry, I cannot summarize a criterion that is not provided. Please provide me with the criterion you would like to have summarized.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1

4 weeks

Treatment

Part 2 of the study will be randomized, treating subjects at selected JV-GL1 doses or Latanoprost for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JV-GL1
• Latanoprost 0.005% Ophthalmic Solution

Participant Groups

Group I: Randomized Part 2, Arm 2 Experimental Treatment 1 Intervention

Dose 2 selected in Part I

Group II: Randomized Part 2, Arm 1 Experimental Treatment 1 Intervention

Dose 1 selected in Part I

Group III: Randomized Part 2, Arm 3 Active Control 1 Intervention

Who Is Running the Clinical Trial?

JeniVision, Inc.

Lead Sponsor

Trials

1

Recruited

70+