Back to resultsStudy of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
brinzolamide 1.0%
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Ocular Hypertension Patients
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
IOP-lowering at 8 and 16 weeks
Secondary Outcome Measures
Safety throughout the 16 weeks of the study
Full Information
NCT ID
NCT00300079
First Posted
March 6, 2006
Last Updated
November 17, 2016
Sponsor
Alcon Research
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00300079
Brief Title
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
Collaborators
University of California, San Diego
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Ocular Hypertension Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
brinzolamide 1.0%
Primary Outcome Measure Information:
Title
IOP-lowering at 8 and 16 weeks
Secondary Outcome Measure Information:
Title
Safety throughout the 16 weeks of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Liu, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19157559
Citation
Liu JH, Medeiros FA, Slight JR, Weinreb RN. Comparing diurnal and nocturnal effects of brinzolamide and timolol on intraocular pressure in patients receiving latanoprost monotherapy. Ophthalmology. 2009 Mar;116(3):449-54. doi: 10.1016/j.ophtha.2008.09.054. Epub 2009 Jan 20.
Results Reference
result
Learn more about this trial
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension
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