Phase 2 N=55 Randomized Double-blind Treatment

Safety and Efficacy of a Glaucoma Drug Delivery System

Glaucoma, Open-Angle · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00824720 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

May 2010

Primary outcome: Primary: Visual Acuity - Right Eye — 0.015; -0.044; -0.012 logMAR units

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: High Dose Device (Drug); Low Dose Device (Drug); Placebo Device (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Vistakon Pharmaceuticals
Primary completion: Apr 2009

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

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.

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.

View full record on ClinicalTrials.gov →

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.