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

  • STATUS
    Recruiting
  • End date
    Jul 2, 2022
  • participants needed
    70
  • sponsor
    JeniVision, Inc.
Updated on 2 April 2021

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.

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 3 doses of JV-GL1: low, medium and high.

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.

Details
Condition EYE DISORDER, Eye Disorders/Infections, Eye Disorders/Infections (Pediatric), Dry Eye Disease, Eye Disease, Ocular Hypertension, Ocular Hypertension, Glaucoma, Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma, Eye Disorders/Infections, Dry Eye Disease, Eye Disorders/Infections (Pediatric), Eye Disease, Open Angle Glaucoma
Treatment Latanoprost 0.005% Ophthalmic Solution, JV-GL1
Clinical Study IdentifierNCT04761705
SponsorJeniVision, Inc.
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria

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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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