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

ForSight Vision5

Status and phase: Completed; Phase 1

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: VISION5 Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01943721

ForSight VISION5 Study 504

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

VISION5 Product

Experimental group

Description:

VISION5 Product in both eyes

Treatment:

Drug: VISION5 Product