Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

• Registration Number: NCT00300079
• Lead Sponsor: Alcon Research

Brief Summary

This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-08
• Study Start: 2006-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-06
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria

• Women of childbearing potential
• History of bronchial asthma, or severe chronic obstructive pulmonary disease
• Presence of acute glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IOP-lowering at 8 and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Safety throughout the 16 weeks of the study