Safety and Efficacy of a Glaucoma Drug Delivery System

Vistakon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Device: Placebo Device; Drug: Low Dose Device; Drug: High Dose Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824720

CR-1630

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

High Dose Device

Experimental group

Description:

device worn continuously for 14 days

Treatment:

Drug: High Dose Device

Low Dose Device

Experimental group

Description:

device worn continuously for 14 days

Treatment:

Drug: Low Dose Device

Placebo Device

Placebo Comparator group

Description:

device worn continuously for 14 days

Treatment:

Device: Placebo Device