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NCT00382226 Clinical Trial

IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Glaucoma Clinical Trial

Official title:
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382226
Other study ID # CM-05-10
Secondary ID
Status Completed
Phase Phase 4
First received September 27, 2006
Last updated November 17, 2016
Start date September 2006
Est. completion date August 2007

Study information
Verified date April 2008
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority Australia: Ministry of Health
Study type Interventional

Clinical Trial Summary

Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Glaucoma

Exclusion Criteria:

- Under 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Azopt

Locations
Country Name City State
Australia Sydney Study Site Sydney New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Goldberg I, Crowston JG, Jasek MC, Stewart JA, Stewart WC; ADAPT Study Investigator Group.. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012 Jan;21(1):55-9. d — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary IOP lowering
Secondary safety
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