Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000067279
Ethics application status
Approved
Date submitted
23/10/2008
Date registered
27/01/2009
Date last updated
5/03/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Bacterial contamination of regular contact lens cases during daily wear of marketed and investigational contact lenses.
Scientific title
Prospective, parallel-group, randomised, open label, bilateral daily wear study to investigate bacterial contamination of regular contact lens cases when used in conjunction with marketed and investigational contact lens.
Universal Trial Number (UTN)
Trial acronym
Contact lens case contamination during daily wear.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial contamination of regular lenses cases when used in conjunction with marketed and antibacterial contact lenses on a daily wear (ie. wearing contact lenses during the day and removing prior to sleep) schedule. 3798 0
Condition category
Condition code
Eye 3978 3978 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of the two groups:
1.Commercially available NIGHT & DAY lenses with regular lens case
2.Investigational antibacterial lenses (AB lenses) with regular 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 and 4 months. Lens cases will be collected for microbiological analysis at 1 month and 4 months.
Intervention code [1] 3519 0
Treatment: Devices
Comparator / control treatment
Active control - Group 1 (commercially available lenses with regular lens case) will act as control
Control group
Active

Outcomes
Primary outcome [1] 4881 0
To assess bacterial contamination of regular lens cases when used in conjunction with investigational or 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 tranfered to 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 microbiology analysis.
Timepoint [1] 4881 0
At 1 month and 4 months from the baseline visit.
Secondary outcome [1] 8242 0
To evaluate ex vivo bacterial adhesion performance of investigational and marketed contact lenses with daily wear schedule. Bacterial assay will be performed on worn and unworn lenses and the results compared.
Timepoint [1] 8242 0
At 1 month and 4 months from the baseline visit.

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;
Be 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
Sex
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 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 beneficial manner;
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;
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised into one of the two parallel groups. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3983 0
Commercial sector/Industry
Name [1] 3983 0
CIBA VISION
Country [1] 3983 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CIBA VISION
Address
11460 Johns Creek Parkway
Duluth, GA 30097-1556
Country
United States of America
Secondary sponsor category [1] 3573 0
None
Name [1] 3573 0
Address [1] 3573 0
Country [1] 3573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6056 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee (VIHEC)
Ethics committee address [1] 6056 0
Ethics committee country [1] 6056 0
Date submitted for ethics approval [1] 6056 0
17/09/2008
Approval date [1] 6056 0
Ethics approval number [1] 6056 0
08/19

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

Contacts
Principal investigator
Name 29012 0
Address 29012 0
Country 29012 0
Phone 29012 0
Fax 29012 0
Email 29012 0
Contact person for public queries
Name 12169 0
Mr Jerome Ozkan
Address 12169 0
Institute for Eye Research
Level 5, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country 12169 0
Australia
Phone 12169 0
+61 2 93857516
Fax 12169 0
+612 93857401
Email 12169 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3097 0
Professor Mark Willcox
Address 3097 0
Institute for Eye Research
Level 4, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW),
Kensington NSW 2052
Country 3097 0
Australia
Phone 3097 0
+61 2 93857516
Fax 3097 0
+61 2 93857401
Email 3097 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.