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

Phase 1CompletedNCT01943721

ForSight Vision5, Inc.14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ocular Hypertension Primary Open Angle Glaucoma

Interventions

VISION5 ProductDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Contact ForSight VISION5 for Trial Locations

Contact ForSight Vision5 For Trial Locations, Latvia

Outcomes

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

Data from ClinicalTrials.gov

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