Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00382226




Registration number
NCT00382226
Ethics application status
Date submitted
27/09/2006
Date registered
28/09/2006
Date last updated
18/11/2016

Titles & IDs
Public title
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Scientific title
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Secondary ID [1] 0 0
CM-05-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IOP lowering
Timepoint [1] 0 0
Secondary outcome [1] 0 0
safety
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Glaucoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Under 18

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
195
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Study Site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT00382226
Trial related presentations / publications
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. doi: 10.1097/IJG.0b013e3181fc8142.
Public notes

Contacts
Principal investigator
Name 0 0
Mark Jasek
Address 0 0
Alcon Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00382226