Phase 2
Completed N=55
Safety and Efficacy of a Glaucoma Drug Delivery System
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT00824720 ↗
Enrolled (actual)
55
Serious AEs
2.0%
Results posted
May 2010
Primary outcomePrimary: Visual Acuity - Right Eye — 0.015; -0.044; -0.012 logMAR units
Summary
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity - Right Eye |
0.015; -0.044; -0.012 | — |
| PRIMARY Visual Acuity - Left Eye |
-0.011; -0.008; -0.019 | — |
| SECONDARY Intraocular Pressure (IOP) |
-1.9; -2.2; -1.3 | 0.9737 |
Eligibility Criteria
Inclusion Criteria
- Man or woman 21 years of age or greater
- must have open angle glaucoma or ocular hypertension.
- Corrected visual acuity in each eye of 20/200 or better.
Exclusion Criteria
- Previous glaucoma intraocular surgery or refractive surgery.
- Planned contact lens use during the study.
- Clinically significant ocular or systemic disease that might interfere with the study.
- Use of chronic corticosteroids by any route.
Data sourced from ClinicalTrials.gov (NCT00824720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.