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Trial registered on ANZCTR


Registration number
ACTRN12609000230257
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
8/05/2009
Date last updated
8/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bacterial adhesion to unworn and worn silicone hydrogel lenses
Scientific title
A prospective, randomised, cross over, open label, bilateral design clinical trial to investigate the differences in the adhesion of various bacteria to a range of silicone hydrogel contact lenses worn by experienced contact lens wearers and to determine whether lens wear modulates adhesion
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of lens wear on bacterial adhesion 3727 0
Condition category
Condition code
Eye 3898 3898 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nine silicone hydrogel lenses (Acuvue Advance, Acuvue Oasys, Acuvue Trueye, Night and Day, Air Optix Aqua, Biofinity, Avaira, Purevision, PremiO) will be tested. Each lens type will be worn by participants on a daily replacement schedule for approximately two weeks with a one day wash out between lens types. A minimum of 3 worn lenses will be collected for each lens type from each participant for bacterial adhesion testing.
Intervention code [1] 3440 0
Treatment: Devices
Comparator / control treatment
Nine unworn silicone hydrogel lenses (Acuvue Advance, Acuvue Oasys, Acuvue Trueye, Night and Day, Air Optix Aqua, Biofinity, Avaira, Purevision, PremiO) will undergo bacterial adhesion testing.
Control group
Active

Outcomes
Primary outcome [1] 4796 0
To establish baseline data for bacterial adhesion to unworn silicone hydrogel lenses. Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface.
Timepoint [1] 4796 0
Six (6) months from baseline.
Primary outcome [2] 5859 0
To identify whether lens wear changes the level of bacterial adhesion to individual lens types.Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface.
Timepoint [2] 5859 0
Six (6) months from baseline
Secondary outcome [1] 241889 0
Identify whether lens wear alters the relative ranking of bacterial adhesion to lenses.Outcome will be assessed using microbial adhesion assay and recovery of viable bacteria attached on the lens surface and comparison of the results between worn and unworn lenses.
Timepoint [1] 241889 0
Six (6) months from baseline.

Eligibility
Key inclusion criteria
Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
Be willing to comply with the 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 participant from safely wearing contact lenses;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses at baseline;
Be experienced at wearing contact lenses at baseline;
Owns spectacles with current prescription.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing ocular irritation, injury or condition of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
Any systemic disease that adversely affects ocular health and auto-immune diseases;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
Any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial;
Participation in a clinical trial within the previous 2 weeks for dispensing studies.

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)
Randomised plan will be generated by a computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3905 0
Charities/Societies/Foundations
Name [1] 3905 0
Institute for Eye Reseach
Address [1] 3905 0
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, Kensington NSW 2052 Australia
Country [1] 3905 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Reseach
Address
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, Kensington NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 3504 0
None
Name [1] 3504 0
Address [1] 3504 0
Country [1] 3504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5964 0
Vision Cooperative Research Centre Ltd and Institute for Eye Research Human Ethics Commitee (VIHEC)
Ethics committee address [1] 5964 0
Level 4, Rupert Myers Building, Gate 14, Barker Street, Kensington NSW 2052 Australia
Ethics committee country [1] 5964 0
Australia
Date submitted for ethics approval [1] 5964 0
20/08/2008
Approval date [1] 5964 0
16/09/2008
Ethics approval number [1] 5964 0
08/14

Summary
Brief summary
To determine differences in the adhesion of various microorganisms on various silicone hydrogel lens materials and to determine whether lens wear modulates this adhesion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28958 0
Address 28958 0
Country 28958 0
Phone 28958 0
Fax 28958 0
Email 28958 0
Contact person for public queries
Name 12115 0
Mr Jerome Ozkan
Address 12115 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, Kensington NSW 2052 Australia
Country 12115 0
Australia
Phone 12115 0
+61 2 93857516
Fax 12115 0
+61 2 93857401
Email 12115 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3043 0
Professor Mark Willcox
Address 3043 0
Institute for Eye Research
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, Kensington NSW 2052 Australia
Country 3043 0
Australia
Phone 3043 0
+61 2 93857516
Fax 3043 0
+61 2 93857401
Email 3043 0
m.willcox@ier.org.au

No data has been provided for results reporting
Summary results
Not applicable