Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Tonometry (change from baseline) | Week 2, 6, 12 and Months 4,5,6 |
Secondary
| Measure | Time frame |
|---|---|
| Safety as assessed by Slit Lamp Exam | Weeks 2,6,12 and Months 4,5,6 |
Countries
Latvia