Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000298516
Ethics application status
Approved
Date submitted
10/07/2006
Date registered
12/07/2006
Date last updated
12/10/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Selenium coated lenses
Scientific title
Evaluation of the safety and efficacy of selenium-coated contact lenses
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 1273 0
Condition category
Condition code
Eye 1360 1360 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of performance of selenium-coated contact lenses to that of high oxygen permeable lenses when worn on a monthly replacement daily or continuous wear schedule for up to 6 months. Subjects will wear the test selenium lens in one eye and the control marketed lens in the other eye
Intervention code [1] 1199 0
Prevention
Comparator / control treatment
marketed lens
Control group
Placebo

Outcomes
Primary outcome [1] 1853 0
To determine whether selenium coated lenses are safe and effective for daily and extended wear. The trial will last for up to 6 months.
Timepoint [1] 1853 0
Assessments will occur on a monthly basis
Secondary outcome [1] 3264 0
To determine whether selenium coated lenses retain antibacterial efficacy after wear.
Timepoint [1] 3264 0
Lenses will be assessed on after each month of wear.

Eligibility
Key inclusion criteria
Be able to read, comprehend and give informed consent as demonstrated by signing a record of informed consent.• be willing to comply with the lens wearing and clinical trial visit schedule as directed by the Investigator.• have ocular health findings considered to be “normal” and which would not prevent the subject from safely wearing contact lenses.• have vision correctable to at least 20/40 or better in each eye with spherical contact lenses.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to hydrogel contact lens wear.• any systemic or ocular disease or active condition or use of medications that may affect the eye or be exacerbated by wearing contact lenses.• pre-existing ocular irritation that would preclude contact lens fitting.• undergone eye surgery in the 12 weeks immediately prior to enrolment for the trial.• undergone corneal refractive surgery.

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)
Randomisation table 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 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1492 0
Charities/Societies/Foundations
Name [1] 1492 0
Institute for Eye Research
Country [1] 1492 0
Australia
Primary sponsor type
Other
Name
Institute for Eye Research
Address
Rupert Myers Building, University of New South Wales, Sydney, NSW
Country
Australia
Secondary sponsor category [1] 1312 0
None
Name [1] 1312 0
None
Address [1] 1312 0
Country [1] 1312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2914 0
Institute for Eye Research
Ethics committee address [1] 2914 0
Ethics committee country [1] 2914 0
Australia
Date submitted for ethics approval [1] 2914 0
Approval date [1] 2914 0
Ethics approval number [1] 2914 0
07/174

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

Contacts
Principal investigator
Name 35429 0
Address 35429 0
Country 35429 0
Phone 35429 0
Fax 35429 0
Email 35429 0
Contact person for public queries
Name 10388 0
Jerome Ozkan
Address 10388 0
Institute for Eye Research
Rupert Myers Building
University of New South Wales
Sydney NSW 2056
Country 10388 0
Australia
Phone 10388 0
+61 2 93857502
Fax 10388 0
+61 2 93857401
Email 10388 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 1316 0
Professor Mark Willcox
Address 1316 0
Institute for Eye Research
Rupert Myers Building
University of New South Wales
Sydney NSW 2056
Country 1316 0
Australia
Phone 1316 0
+61 2 93857412
Fax 1316 0
+61 2 93857401
Email 1316 0
m.willcox@ier.org.au

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.