Safety and Efficacy of a Drug Delivery System in Glaucoma

Phase 2

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Placebo Device; Drug: High Dose Drug Device; Drug: Low Dose Drug Device; Drug: bimatoprost 0.03%

• Registration Number: NCT01016691
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-18
• Study First Posted: 2009-11-19
• Primary Completion: 2010-02
• Results First Submitted: 2011-09-26
• Results First Submitted QC: 2011-12-20
• Results First Posted: 2012-01-27
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Drug Device/ bimatoprost 0.03%	bimatoprost 0.03%	drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Low Dose Drug Device / bimatoprost 0.03%	bimatoprost 0.03%	drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Placebo Device / bimatoprost 0.03%	Placebo Device	placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
High Dose Drug Device/ bimatoprost 0.03%	High Dose Drug Device	drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Low Dose Drug Device / bimatoprost 0.03%	Low Dose Drug Device	drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Placebo Device / bimatoprost 0.03%	bimatoprost 0.03%	placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

Primary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure at Day 1	Baseline to Day 1

Secondary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure at Day 4	Baseline to Day 4
Mean Change in Intraocular Pressure at Day 3	Baseline to Day 3
Mean Change in Intraocular Pressure at Day 2	Baseline to Day 2
Mean Change in Intraocular Pressure at Day 5	Day 4 to Day 5