Overview

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

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ForSight Vision5, Inc.
Criteria
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