Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000199011
Ethics application status
Not yet submitted
Date submitted
11/02/2010
Date registered
9/03/2010
Date last updated
9/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative Study of the Efficacy and Safety of two presentations of Bimatoprost 0.03% available in Brazil: Glamigan(registered trademark) and Lumigan(registered trademark).
Scientific title
In glaucoma or ocular hypertension, have the two presentations of bimatoprost 0.03% availabe in Brazil similar safety and efficacy profile?
Secondary ID [1] 1430 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glacoma 256798 0
ocular hypertension 256799 0
Condition category
Condition code
Eye 256952 256952 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
bimatoprost 0.03% eye drops: Lumigan(registered trademark) versus Glamigan(registered trademark), 45 days of treatment with each
Intervention code [1] 256007 0
Treatment: Drugs
Comparator / control treatment
cross-over study: the same individual will use both bimatoprost 0.03% presentations at different time frames, and collected data will be compared. Lumigan(registered trademark) treatment cycle versus Glamigan(registered trademark) treatment cycle, 45 days each cycle, witha a 30-day washout period in between.
Control group
Active

Outcomes
Primary outcome [1] 257825 0
diurnal curve of intraocular pressure (Goldmann Applanation Tonometry, at 08:00, 10:00, 12:00, 14:00, 16:00, 18:00)
Timepoint [1] 257825 0
Basal Visit (time 0 - no medication)
Visit 1 (15 days with medication A)
Visit 2 (45 days with medication A)
Visit 3 (after 30 days of washout of medication A and 15 days with medication B)
Visit 4 (45 days with medication B)
Secondary outcome [1] 263242 0
Visual Acuity (logMAR)
Timepoint [1] 263242 0
Basal Visit (time 0 - no medication)
Visit 1 (15 days with medication A)
Visit 2 (45 days with medication A)
Visit 3 (after 30 days of washout of medication A and 15 days with medication B)
Visit 4 (45 days with medication B)
Secondary outcome [2] 263243 0
Ocular Surface Disease Index (OSDI)
Timepoint [2] 263243 0
Basal Visit (time 0 - no medication)
Visit 1 (15 days with medication A)
Visit 2 (45 days with medication A)
Visit 3 (after 30 days of washout of medication A and 15 days with medication B)
Visit 4 (45 days with medication B)
Secondary outcome [3] 263244 0
Disk Damage Likelihood Scale - DDLS
Timepoint [3] 263244 0
Basal Visit (time 0 - no medication)
Visit 1 (15 days with medication A)
Visit 2 (45 days with medication A)
Visit 3 (after 30 days of washout of medication A and 15 days with medication B)
Secondary outcome [4] 263245 0
Ocular Inflammation (laser flare meter)
Timepoint [4] 263245 0
Basal Visit (time 0 - no medication)
Visit 1 (15 days with medication A)
Visit 2 (45 days with medication A)
Visit 3 (after 30 days of washout of medication A and 15 days with medication B)

Eligibility
Key inclusion criteria
Ocular Hypertension:
- intraocular pressure higher than 21mmHg with no medication
-normal visual field test
-normal optic nerve appearance

Glaucoma:
-intraocular pressure higher than 21mmHg with no medication
-glaucomatous visual filed test
-glacuomatous optic nerve appearance
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- visual acuity worse than 20/40 (Snellen scale)
- intraocular pressure higher than 36mmHg with medication
- diabetes
-intraocular laser or surgery on the last 6 months
-ocular trauma on the last 6 months

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 2492 0
Brazil
State/province [1] 2492 0

Funding & Sponsors
Funding source category [1] 256509 0
Commercial sector/Industry
Name [1] 256509 0
Germed Pharma ltda
Country [1] 256509 0
Brazil
Primary sponsor type
University
Name
Ophthalmology Department of the State University of Campinas
Address
Rua Vital Brasil, 251
Distrito de Barao Geraldo
Campinas
Sao Paulo
Country
Brazil
Secondary sponsor category [1] 255858 0
None
Name [1] 255858 0
Address [1] 255858 0
Country [1] 255858 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258556 0
Ethics in Resear Board of the State University of Campinas
Ethics committee address [1] 258556 0
Rua Tessalia Vieira de Camargo, 126
Distrito de Barao Geraldo
Campinas
Sao Paulo
Ethics committee country [1] 258556 0
Brazil
Date submitted for ethics approval [1] 258556 0
01/03/2010
Approval date [1] 258556 0
Ethics approval number [1] 258556 0

Summary
Brief summary
The primary purpose of the study is to compare the safety and efficacy of the two avalable presentations of bimatoprost 0.03% in Brazil. We intent to compare the reduction of the intraoclular pressure with the two deifferent presentations and observe the incidence of side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30830 0
Address 30830 0
Country 30830 0
Phone 30830 0
Fax 30830 0
Email 30830 0
Contact person for public queries
Name 14077 0
Alvaro Lupinacci
Address 14077 0
Rua Hermantino Coelho, 501 apto 144W
CEP 13027-500
Campinas - Sao Paulo
Country 14077 0
Brazil
Phone 14077 0
55-19-33676432
Fax 14077 0
Email 14077 0
[email protected]
Contact person for scientific queries
Name 5005 0
Alvaro Lupinacci
Address 5005 0
Rua Hermantino Coelho, 501 apto 144W
CEP 13027-500
Campinas - Sao Paulo
Country 5005 0
Brazil
Phone 5005 0
55-19-33676432
Fax 5005 0
Email 5005 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.