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Completed

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

ClinicalTrials.gov ID NCT01943721
Sponsor ForSight Vision5, Inc.
Information provided by ForSight Vision5, Inc. (Responsible Party)
Last Update Posted 2014-12-17
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Study Overview

Brief Summary
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
Official Title
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Conditions
Ocular Hypertension
Primary Open Angle Glaucoma
Intervention / Treatment
  • Drug: VISION5 Product
  • Drug: VISION5 Product
Other Study ID Numbers
  • ForSight VISION5 Study 504
Study Start
2013-10
Primary Completion (Actual)
2014-06
Study Completion (Actual)
2014-06
Enrollment (Actual)
14
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Prevention
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: VISION5 Product
VISION5 Product in both eyes
Intervention/Treatment Drug: VISION5 Product
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Ocular Tonometry (change from baseline) Week 2, 6, 12 and Months 4,5,6
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Safety as assessed by Slit Lamp Exam Weeks 2,6,12 and Months 4,5,6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
ForSight Vision5, Inc.
Investigators
  • Study Director:Anne Rubin,ForSight VISION5

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2013-09-10
First Submitted that Met QC Criteria
2013-09-12
First Posted (Estimated)
2013-09-17
Study Record Updates
Last Update Submitted that met QC Criteria
2014-12-15
Last Update Posted (Estimated)
2014-12-17
Last Verified
2014-12

More Information

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Additional Relevant MeSH Terms