Safety and Efficacy of a Drug Delivery System in Glaucoma

Phase 2CompletedNCT01016691

Vistakon Pharmaceuticals47 enrolled

Overview

Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Open-angle Glaucoma Ocular Hypertension

Interventions

High Dose Drug DeviceDRUG

device inserted for 4 days

Low Dose Drug DeviceDRUG

device inserted for 4 days

Placebo DeviceDRUG

device inserted for 4 days

bimatoprost 0.03%

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Miami, Florida, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Unnamed facility

Mt. Pleasant, South Carolina, United States

Unnamed facility

Rapid City, South Dakota, United States

Unnamed facility

Outcomes

Primary Outcomes

Mean Change in Intraocular Pressure at Day 1

Time frame: Baseline to Day 1

Secondary Outcomes

Mean Change in Intraocular Pressure at Day 2

Time frame: Baseline to Day 2

Mean Change in Intraocular Pressure at Day 3

Time frame: Baseline to Day 3

Mean Change in Intraocular Pressure at Day 4

Time frame: Baseline to Day 4

Mean Change in Intraocular Pressure at Day 5

Time frame: Day 4 to Day 5

Data from ClinicalTrials.gov

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