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NCT00300079 Clinical 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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00300079
Other study ID # CM-05-13
Secondary ID CM-05-13
Status Completed
Phase Phase 4
First received March 6, 2006
Last updated November 17, 2016
Start date September 2006
Est. completion date September 2007

Study information
Verified date June 2008
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• brinzolamide 1.0%

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Alcon Research University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary IOP-lowering at 8 and 16 weeks
Secondary Safety throughout the 16 weeks of the study
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