Safety and Efficacy of a Glaucoma Drug Delivery System

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Device: Placebo Device; Drug: High Dose Device; Drug: Low Dose Device

• Registration Number: NCT00824720
• Lead Sponsor: Vistakon Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-19
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-04-15
• Results First Submitted QC: 2010-04-15
• Results First Posted: 2010-05-14
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Device	Placebo Device	device worn continuously for 14 days
High Dose Device	High Dose Device	device worn continuously for 14 days
Low Dose Device	Low Dose Device	device worn continuously for 14 days

Primary Outcome Measures

Name	Time	Method
Visual Acuity - Right Eye	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	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 Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	from baseline to 14 days