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Trial registered on ANZCTR


Registration number
ACTRN12609000165280
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
3/04/2009
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Bacterial contamination of antibacterial contact lens cases during daily wear of marketed contact lenses
Scientific title
Prospective, single-group, open label, bilateral daily wear study to investigate bacterial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses in healthy volunteers
Secondary ID [1] 259839 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Antibacterial contact lens case contamination during daily wear
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial contamination of antibacterial lens cases when used in conjunction with marketed contact lenses on a daily wear (ie. wearing contact lenses during the day and removing prior to sleep) schedule 4347 0
Condition category
Condition code
Eye 4588 4588 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be dispensed with commercially available Purevision (balafilcon A) lenses with antibacterial lens case. Participants will wear lenses on a daily wear (ie. not sleeping in the lenses) basis for 4 months. Lens performance will be assessed at the baseline visit, and after 2 weeks, 1 month, 3 months and 4 months. Lens cases will be collected for microbiological analysis at the monthly visits. All participants will use the same brand of lenses and antibacterial lens case
Intervention code [1] 4078 0
Treatment: Devices
Comparator / control treatment
Historical control. The study to which we will be comparing this study used the same lens type, solution and similar visit schedule (up to the 3 month visit) as the current study, the only difference is the type of lens case used. In the historical control a regular lens case was used.
Control group
Historical

Outcomes
Primary outcome [1] 5464 0
To assess bacterial contamination of antibacterial lens cases when used in conjunction with marketed contact lenses on a daily wear (ie. contact lenses worn during the day and removed prior to sleep) schedule. Used contact lens storage cases will be collected at the end of the clinical trial and transferred to the Institute for Eye Research (IER) microbiology laboratory. Swab samples will be taken from inner surfaces of lens cases for routine microbiology isolation and identification. Contamination rate of used cases will be then determined based on data from microbiological analysis
Timepoint [1] 5464 0
At 1 month, 3 months and 4 months from the baseline visit
Secondary outcome [1] 9206 0
None
Timepoint [1] 9206 0
N/A

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
Be experienced or may be inexperienced at wearing contact lenses
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 that would preclude contact lens fitting and safe wearing of contact lenses;
Any systemic disease that adversely affects ocular health;
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 beneficial manner;
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;
Allergy or intolerance to silver;
Pregnant women are excluded from the trial - formal testing of pregnancy is not required. A participant's verbal report is sufficient.

Study design
Purpose of the study
Prevention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 4526 0
Charities/Societies/Foundations
Name [1] 4526 0
Institute for Eye Research
Address [1] 4526 0
Level 5, Rupert Myers Building
Gate 14, Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country [1] 4526 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Level 5, Rupert Myers Building
Gate 14, Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 4087 0
None
Name [1] 4087 0
Address [1] 4087 0
Country [1] 4087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6579 0
Vision Cooperative Research Ventre and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 6579 0
Ethics committee country [1] 6579 0
Date submitted for ethics approval [1] 6579 0
18/03/2009
Approval date [1] 6579 0
Ethics approval number [1] 6579 0

Summary
Brief summary
hypotheses for this study include:
Study hypothesis is that antibacterial lens cases will have less contamination inside the lens storage case than a regular lens case. Primary purpsoe of the study is to assess bacterial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses worn on a daily wear and monthly replacement schedule and to compare the results to a historical control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29302 0
Address 29302 0
Country 29302 0
Phone 29302 0
Fax 29302 0
Email 29302 0
Contact person for public queries
Name 12549 0
Mr Jerome Ozkan
Address 12549 0
Institute for Eye Research
Level 5, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country 12549 0
Australia
Phone 12549 0
+61 2 93857516
Fax 12549 0
+61 2 93857401
Email 12549 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3477 0
Professor Mark Willcox
Address 3477 0
Institute for Eye Research
Level 4, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country 3477 0
Australia
Phone 3477 0
+61 2 93857516
Fax 3477 0
+61 2 93857401
Email 3477 0
m.willcox@ier.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary