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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00300079
• Collaborator: University of California, San Diego (Other)
• Enrollment: 30
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension	Drug: brinzolamide 1.0%	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. IOP-lowering at 8 and 16 weeks []

Secondary Outcome Measures

1. Safety throughout the 16 weeks of the study []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States

Sponsors and Collaborators

• Alcon Research
• University of California, San Diego

Investigators

• Principal Investigator: John Liu, PhD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00300079
• Other Study ID Numbers: CM-05-13; CM-05-13
• First Posted: Mar 8, 2006
• Last Update Posted: Nov 18, 2016
• Last Verified: Jun 1, 2008

• Keywords provided by Alcon Research: Ocular Hypertension Patients
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Brinzolamide

Study Results

No Results Posted as of Nov 18, 2016