Phase 2
Completed N=47
Safety and Efficacy of a Drug Delivery System in Glaucoma
Source: ClinicalTrials.gov NCT01016691 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Mean Change in Intraocular Pressure at Day 1 — -4.16; -4.57; -0.60 mmHg
Summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Intraocular Pressure at Day 1 |
-4.16; -4.57; -0.60 | — |
| SECONDARY Mean Change in Intraocular Pressure at Day 2 |
— | — |
| SECONDARY Mean Change in Intraocular Pressure at Day 3 |
— | — |
| SECONDARY Mean Change in Intraocular Pressure at Day 4 |
— | — |
| SECONDARY Mean Change in Intraocular Pressure at Day 5 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Man or woman 21 years of age or greater
- 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 (NCT01016691). 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.