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...
Date First Received: March 6, 2006
Last Updated: June 23, 2008
Verified by: Alcon Research, June 2008
Clinical Trial Phase: Phase 4 | Start Date: September 2006
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Study Primary Completion Date: September 2007
Intervention(s) in this Clinical Trial
- Drug: brinzolamide 1.0%
Outcome Measures for this Clinical Trial
Primary Measures
- IOP-lowering at 8 and 16 weeks
Secondary Measures
- Safety throughout the 16 weeks of the study
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Overall Clinical Trial Officials and Contacts
John Liu, PhD Principal Investigator University of California, San Diego
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300079
Study ID Number: CM-05-13
ClinicalTrials.gov Identifier: NCT00300079
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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