Safety and Efficacy of a Glaucoma Drug Delivery System
Overview
- Phase
- Phase 2
- Intervention
- High Dose Device
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Vistakon Pharmaceuticals
- Enrollment
- 55
- Primary Endpoint
- Visual Acuity - Right Eye
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
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.
Arms & Interventions
High Dose Device
device worn continuously for 14 days
Intervention: High Dose Device
Low Dose Device
device worn continuously for 14 days
Intervention: Low Dose Device
Placebo Device
device worn continuously for 14 days
Intervention: Placebo Device
Outcomes
Primary Outcomes
Visual Acuity - Right Eye
Time Frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity - Left Eye
Time Frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Secondary Outcomes
- Intraocular Pressure (IOP)(from baseline to 14 days)