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

JeniVision

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: JV-GL1; Drug: Latanoprost 0.005% Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04761705

JV-GL1-OCU-GL-101/201-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• bilateral open-angle glaucoma or ocular hypertension

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Randomized Part 2, Arm 1

Experimental group

Description:

Dose 1 selected in Part I

Treatment:

Drug: JV-GL1

Randomized Part 2, Arm 2

Experimental group

Description:

Dose 2 selected in Part I

Treatment:

Drug: JV-GL1

Randomized Part 2, Arm 3

Active Comparator group

Treatment:

Drug: Latanoprost 0.005% Ophthalmic Solution