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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


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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