Safety and Efficacy Study of JV-GL1 in Patients With Open... | NCT04761705

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

NCT04761705

Sponsor

JeniVision, Inc.

Status

Suspended

Last Update Posted

May 10, 2024Actual

Enrollment

70Estimated

Phase

Phase 1Phase 2

Conditions

Ocular Hypertension
Open Angle Glaucoma

Interventions

JV-GL1
Latanoprost 0.005% Ophthalmic Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Awaiting transition to Part 2

Expanded Access Info

Start Date

Mar 10, 2021Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2024

Last Update Posted Date

May 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Randomized Part 2, Arm 1	Experimental	Dose 1 selected in Part I	Drug: JV-GL1
Randomized Part 2, Arm 2	Experimental	Dose 2 selected in Part I	Drug: JV-GL1
Randomized Part 2, Arm 3	Active Comparator		Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JV-GL1	Drug	Experimental Treatment	Randomized Part 2, Arm 1 Randomized Part 2, Arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular Pressure (IOP)	Change from baseline in Intraocular Pressure (IOP)	From Baseline to Day 28 of Treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Wirta, MD	Eye Research Foundation, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Research Foundation		Newport Beach	California	92663	United States

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005128	Eye Diseases
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077338	Latanoprost
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided