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

Phase 1

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: VISION5 Product

• Registration Number: NCT01943721
• Lead Sponsor: ForSight Vision5, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VISION5 Product	VISION5 Product	VISION5 Product in both eyes

Primary Outcome Measures

Name	Time	Method
Ocular Tonometry (change from baseline)	Week 2, 6, 12 and Months 4,5,6

Secondary Outcome Measures

Name	Time	Method
Safety as assessed by Slit Lamp Exam	Weeks 2,6,12 and Months 4,5,6

Trial Locations

Locations (1)

Contact ForSight VISION5 for Trial Locations; 🇱🇻 Contact ForSight VISION5 for Trial Locations, Latvia