A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Primary Open Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Contact ForSight VISION5 for Trial Locations

Contact ForSight Vision5 For Trial Locations, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent
Primary open-angle glaucoma or ocular hypertension in both eyes
Best-corrected distance vision of 20/100 or better
Stable visual field

Exclusion criteria

Cup-to-disc ratio greater than 0.8
Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
Corneal refractive surgery within prior 6 months
Past history of any incisional surgery for glaucoma at any time
Corneal abnormalities that would interfere with tonometry readings
Current participation in an investigational drug or device study or participation in such a study within 30 days of screening

Treatment and study plan

VISION5 Product

Drug

Primary outcomes

Ocular Tonometry (change from baseline)

Time frame: Week 2, 6, 12 and Months 4,5,6

Secondary outcomes

Safety as assessed by Slit Lamp Exam

Time frame: Weeks 2,6,12 and Months 4,5,6

Sponsors and collaborators

Lead sponsor

ForSight Vision5, Inc.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Sep 17, 2013
Registry last updated: Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed