Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000247875
Ethics application status
Approved
Date submitted
22/02/2012
Date registered
28/02/2012
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of the fixed combination Timolol 0,5%/Travoprost 0,004% compared the concomitant administration to the single components.
Scientific title
Effect of the fixed versus unfixed combination of timolol and travoprost on intraocular pressure in 40 Caucasian patients with primary open angle glaucoma or ocular hypertension in 6 months follow up period.
Secondary ID [1] 280015 0
Nil
Universal Trial Number (UTN)
U1111-1128-3742
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary open angle glaucoma 285926 0
Ocular hypertension 285955 0
Condition category
Condition code
Eye 286114 286114 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of timolol and travoprost in treatment of primary open angle glaucoma.
Arm 1-Timolol 0,5% twice daily was instilled for 30 days in 80 eyes
Arm 2- Timolol 0,5% twice daily and travoprost 0,004% once a day were instilled for 30 days.
Arm 3- Fixed combination of timolol 0,5% /travoprost 0,004% once a day were instilled for 30 days.
The mode of instillation of these treatments is self-administration
Intervention code [1] 284336 0
Treatment: Drugs
Comparator / control treatment
Standard treatment consists of administration of eye drop to low intraocular pressure.
The timolol is self aministratione twice daily and it is the standard treatment
The travoprost is self admiistration once a day.
The fixed combination timolol/travoprost is administration once a day.
The duration of use of these treatments ic chronic.
Control group
Active

Outcomes
Primary outcome [1] 286591 0
Reduction of the intraocular pressure with different combination of eye drop. This is assessed by Goldmann applanation tonometry.
Timepoint [1] 286591 0
At 30,60,90 days after treatment
Secondary outcome [1] 296224 0
Maintain low intraocular pressure during 24 hour,using fixed combination timolol/travoprost once a day.
This is assessed by Goldmann applanation tonometry.
Timepoint [1] 296224 0
At 120,180 days after treatment.

Eligibility
Key inclusion criteria
Patients over 18 years with clinical diagnosis of primary open angle glaucoma or ocular hypertension who had been treated with any therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormal corneal sensation, condition preventing tonometry, ocular opacity or insufficient dilation preventing retinal evaluation, narrow anterior chamber angle, inflammatory ocular surface disease, anterior/posterior uveitis, ocular inflammation/infection, progressive retinal disease, significant ocular signs/symptoms, allergic conjunctivitis, significant visual field defect or progressive visual field loss within the last year, history of certain ocular surgeries, significant cardiovascular disease, and history of pulmonary disease including asthma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4169 0
Italy
State/province [1] 4169 0
Rome

Funding & Sponsors
Funding source category [1] 284769 0
University
Name [1] 284769 0
"La Sapienza"
Country [1] 284769 0
Italy
Primary sponsor type
Individual
Name
Luigi Mazzeo,Md
Address
155 V.le del Policlinico, 00161 – Rome
Country
Italy
Secondary sponsor category [1] 283660 0
Individual
Name [1] 283660 0
Elena Pacella,MD
Address [1] 283660 0
155 V.le del Policlinico, 00161 Rome
Country [1] 283660 0
Italy
Other collaborator category [1] 260569 0
Individual
Name [1] 260569 0
Francesco Mazzeo,MD
Address [1] 260569 0
155 V.le del Policlinico, 00161 Rome
Country [1] 260569 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286764 0
Ethics Committee of the Department of Ophthalmology of the University La Sapienza of Rome
Ethics committee address [1] 286764 0
Ethics committee country [1] 286764 0
Italy
Date submitted for ethics approval [1] 286764 0
Approval date [1] 286764 0
25/01/2011
Ethics approval number [1] 286764 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33825 0
Address 33825 0
Country 33825 0
Phone 33825 0
Fax 33825 0
Email 33825 0
Contact person for public queries
Name 17072 0
Luigi Mazzeo,MD
Address 17072 0
155 V.le del Policlinico, 00161 – Rome – Italy
Country 17072 0
Italy
Phone 17072 0
+39 0649975302
Fax 17072 0
+39 0649975304
Email 17072 0
[email protected]
Contact person for scientific queries
Name 8000 0
Luigi Mazzeo,MD
Address 8000 0
155 V.le del Policlinico, 00161 – Rome – Italy
Country 8000 0
Italy
Phone 8000 0
+39 0649975302
Fax 8000 0
+39 0649975304
Email 8000 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.