Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001034022
Ethics application status
Not yet submitted
Date submitted
21/11/2010
Date registered
24/11/2010
Date last updated
24/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison Between the Effectiveness of Fixed Combinations of Prostaglandin Analogues
Scientific title
Comparison Between the Effectiveness of Fixed Combinations of Prostaglandin Analogues Regarding Intraocular Pressure Control
Secondary ID [1] 253131 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary open angle glaucoma 258688 0
Ocular hypertension 258690 0
Condition category
Condition code
Eye 258836 258836 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will use fixed combinations of prostaglandin analogues plus topical beta blockers available on market during 60 days. Patients will be divided in three groups. Each group will recieve one drug. Intraocular pressure will be compared.
If using drugs prior to study, a washout period of 30 days will be necessary.
Half of patients will receive the drug at mornig (8 a.m.) and half at night (8 p.m.). After 30 days they will change the time to use the drug (crossover regarding the instillation time), without washout between these change.
The drugs are: Xalacom (latanoprost 0.005%/timolol 0.5%) eye drop once day; Ganfort (bimatoprost 0.03%/timolol 0.5%) eye drop once day; and Duotrav (travoprost 0.004%/timolol 0.5%) eye drop once day.
Intervention code [1] 257648 0
Treatment: Drugs
Comparator / control treatment
The control will be the patient before treatment.
Intraocular pressure behavior will be compared between groups.
Control group
Active

Outcomes
Primary outcome [1] 259697 0
Intraocular pressure measurement by applanation tonometry (Goldmann Applanation Tonometer)
Timepoint [1] 259697 0
Baseline
30 days
60 days
Secondary outcome [1] 266403 0
Adverse effects at 30 days self reported such as hyperemia, itching, blurring.
Timepoint [1] 266403 0
30 days

Eligibility
Key inclusion criteria
Intra ocular pressure over 21 MMHG
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

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)
Intraocular pressure higher than 21 mmhg
Need to use drops to reduce intraocular pressure
One investigator will evaluate the patients, enroll them and proceed the allocation after use a randomised number generate by a computer program. He will give the drug to the patient and will not participate from statistical analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Program at randomizer.org site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3060 0
Brazil
State/province [1] 3060 0
Mato Grosso do Sul
CEP: 79000-000
Country [2] 3061 0
Brazil
State/province [2] 3061 0
MS

Funding & Sponsors
Funding source category [1] 258112 0
Self funded/Unfunded
Name [1] 258112 0
Country [1] 258112 0
Brazil
Primary sponsor type
Individual
Name
Enyr Saran Arcieri
Address
Rua Francisco Sales, 186
Uberlandia - MG - BRAZIL
CEP 38411-092
Country
Brazil
Secondary sponsor category [1] 257292 0
None
Name [1] 257292 0
Address [1] 257292 0
Country [1] 257292 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260097 0
Uniderp Ethics Committee
Ethics committee address [1] 260097 0
City: Campo Grande
State: Mato Grosso do Sul (MS)
CEP: 79000-000
Ethics committee country [1] 260097 0
Brazil
Date submitted for ethics approval [1] 260097 0
01/08/2010
Approval date [1] 260097 0
Ethics approval number [1] 260097 0

Summary
Brief summary
Patients with primary open angle glaucoma or ocular hypertensio will be treated with fixed combinations of prostaglandin analogues plus beta blocker.
They will be follow for 60 days.
Intraocular pressure will be compared. Comparisons beteween groups and with baseline.
Trial website
None
Trial related presentations / publications
Not yet
Public notes

Contacts
Principal investigator
Name 31938 0
Address 31938 0
Country 31938 0
Phone 31938 0
Fax 31938 0
Email 31938 0
Contact person for public queries
Name 15185 0
Enyr Saran Arcieri
Address 15185 0
Rua Francisco Sales, 186
Uberlandia - Minas Gerais - Brazil
CEP 38411-092
Country 15185 0
Brazil
Phone 15185 0
553432364540
Fax 15185 0
Email 15185 0
[email protected]
Contact person for scientific queries
Name 6113 0
Enyr Saran Arcieri
Address 6113 0
Rua Francisco Sales, 186
Uberlandia - Minas Gerais - Brazil
CEP 38411-092
Country 6113 0
Brazil
Phone 6113 0
553432364540
Fax 6113 0
Email 6113 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.