Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000297527
Ethics application status
Approved
Date submitted
10/07/2006
Date registered
12/07/2006
Date last updated
12/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Dispensing evaluation of antibacterial lenses
Scientific title
Evaluation of antibacterial furanone-coated contact lens for safe overnight or daily wear
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 1272 0
Condition category
Condition code
Eye 1359 1359 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of the performance of antibacterial furanone contact lenses to standard marketed highly oxygen permeable contact lenses with overnight wear on a 30 day diposable basis. The study may continue for up to 6 months. Subjects will wear a test antibacterial lens in one eye, and the control marketed lens in the other eye.
Intervention code [1] 1198 0
Prevention
Comparator / control treatment
standard marketed highly oxygen permeable contact lenses
Control group
Placebo

Outcomes
Primary outcome [1] 1852 0
Ocular health of subjects
Timepoint [1] 1852 0
During wear on a monthly basis
Secondary outcome [1] 3263 0
Contact lens contamination
Timepoint [1] 3263 0
On a monthly basis.

Eligibility
Key inclusion criteria
Able to read, comprehend and sign a record of informed consent• Willing to comply with the wearing and study visit schedule as directed by the investigator;•Have a need for correction in both eyes and be correctable with spherical hydrogel contact lenses.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any systemic or ocular condition that may preclude safe wearing of contact lenses (e.g. active corneal infection, severe dry eye, hypoesthesia).

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



Intervention assignment
Parallel
Other design features
Test lens in one eye, control lens in the other eye
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1490 0
Charities/Societies/Foundations
Name [1] 1490 0
Institute for Eye Research
Country [1] 1490 0
Australia
Funding source category [2] 1491 0
Commercial sector/Industry
Name [2] 1491 0
Biosignal Pty Ltd
Country [2] 1491 0
Australia
Primary sponsor type
Other
Name
Institute for Eye Research
Address
Country
Australia
Secondary sponsor category [1] 1311 0
Commercial sector/Industry
Name [1] 1311 0
Biosignal Pty Ltd
Address [1] 1311 0
Country [1] 1311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2913 0
Institute for Eye Research
Ethics committee address [1] 2913 0
Ethics committee country [1] 2913 0
Australia
Date submitted for ethics approval [1] 2913 0
Approval date [1] 2913 0
Ethics approval number [1] 2913 0
IERP2005-007

Summary
Brief summary
To determine whether an antibacterial contact lens can prevent bacterial colonisation of the lens during wear, and can be worn safely. Both the dispensing optometrist and subject wearing lenses will be masked to which lens is being used
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36402 0
Address 36402 0
Country 36402 0
Phone 36402 0
Fax 36402 0
Email 36402 0
Contact person for public queries
Name 10387 0
Jerome Ozkan
Address 10387 0
Institute for Eye Research
Rupert Myers Building
University of New South Wales
Sydney NSW 2052
Country 10387 0
Australia
Phone 10387 0
+61 2 93857502
Fax 10387 0
+61 2 93857401
Email 10387 0
[email protected]
Contact person for scientific queries
Name 1315 0
Prof Mark Willcox
Address 1315 0
Institute for Eye Research
Rupert Myers Building
University of New South Wales
Sydney NSW 2052
Country 1315 0
Australia
Phone 1315 0
+61 2 93857412
Fax 1315 0
+61 2 93857401
Email 1315 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.