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

NCT ID: NCT01943721

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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Conditions

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Ocular Hypertension Primary Open Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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VISION5 Product

VISION5 Product in both eyes

Group Type EXPERIMENTAL

VISION5 Product

Intervention Type DRUG

Interventions

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VISION5 Product

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ForSight Vision5, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Rubin

Role: STUDY_DIRECTOR

ForSight VISION5

Locations

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Contact ForSight VISION5 for Trial Locations

Contact ForSight Vision5 For Trial Locations, , Latvia

Site Status

Countries

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Latvia

Other Identifiers

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ForSight VISION5 Study 504

Identifier Type: -

Identifier Source: org_study_id