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Trial registered on ANZCTR


Registration number
ACTRN12617001607369
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
7/12/2017
Date last updated
7/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the ability of silver contact lens storage cases to control bacterial contamination
Scientific title
Study to evaluate the frequency of microbial contamination of silver versus non-silver contact lens storage cases in daily wear soft contact lens wear
Secondary ID [1] 293236 0
SOVS 2016-099
Universal Trial Number (UTN)
Nil known
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Contact lens case contamination in asymptomatic contact lens wearer 305274 0
Condition category
Condition code
Eye 304589 304589 0 0
Diseases / disorders of the eye
Infection 304712 304712 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being administered is silver-impregnated antimicrobial contact lens storage cases manufactured by Sauflon, UK (owned by CooperVision, CA, USA). After daily lens wear, participants will remove their contact lenses, clean them using the study provided multipurpose cleaning and disinfecting solution, and store their contact lenses in the experimental silver lens cases for overnight disinfection in the multipurpose solution. The experimental silver lens cases will be used for one month, and the order in which participants will be exposed to the experimental (and control) contact lens cases will be randomly assigned. The study contact lens storage cases will be distributed to participants for use at home, in plain unmarked study envelopes to maintain investigator masking. The used contact lens cases will be returned to the investigator after one-month and two-month at the scheduled follow-up visit.
Intervention code [1] 299494 0
Treatment: Devices
Comparator / control treatment
In this study, the active control is contact lens storage cases of the same shape and design of the experimental silver lens cases, manufactured by Sauflon, UK (owned by CooperVision, CA, USA), but without impregnation of silver to the lens case. After daily lens wear, participants will remove their contact lenses, clean them using the study provided multipurpose cleaning and disinfecting solution, and store their contact lenses in the non-silver lens cases for overnight disinfection in the multipurpose solution. The control non-silver lens cases will be used for one month, and the order in which participants will be exposed to the control (and experimental) contact lens cases will be randomly assigned. The study contact lens storage cases will be distributed to participants for use at home, in plain unmarked study envelopes to maintain investigator masking. The used contact lens cases will be returned to the investigator after one-month and two-month at the scheduled follow-up visits.
Control group
Active

Outcomes
Primary outcome [1] 303803 0
The (proportion) percentage of lens case contamination will be compared between silver and non-silver barrel cases.
In order to assess contact lens cases for microbial contamination, lens cases will be sent to the microbiology laboratory within one hour of collection, where an unmasked researcher (experienced in microbiology work more than 5 years) will be swabbed with a cotton swab from the lens cases and the recovery of microorganisms will be assessed using the microbial culture method.
Timepoint [1] 303803 0
1 month
Secondary outcome [1] 340238 0
To identify the types of micro-organisms recovered from silver-impregnated barrel cases and non-silver lens cases. After the microbial culture collection from the contact lens cases, and bacterial identification will be conducted using 16rRNA PCR (polymerase chain reaction) technique.
Timepoint [1] 340238 0
1 month

Eligibility
Key inclusion criteria
Be at least 18 years of age;
• An existing contact lens wearer (hydrogel or silicone hydrogel) not currently wearing daily disposable contact lenses;
• Willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week (on average) for the duration of the study;
• Willing to use the study prescribed contact lens case and disinfecting solution for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Daily disposable or rigid gas permeable lens wearer (including ortho-keratology);
• Non-contact lens wearer;
• Self-reported metal/silver sensitivity/allergy;
• Any active corneal infection, ocular disease or systemic disease that would affect wearing of contact lenses;
• Use of or need for any systemic 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;
• Contraindications to contact lens wear;
• Currently enrolled in another clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested people who respond to the study advertisement will be asked to provide written informed consent prior to any procedures being conducted. Only those who meet the eligibility criteria will continue in the study. With the help of an unmasked researcher, the trial devices will be allocated based on the concealed envelopes marked with the study code of participants' identification number and the visit number. Participants' will receive either the silver or non-silver lens cases at their first or second visit based on a predetermined randomization scheme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
"Simple randomisation using a randomisation table created by computer software (i.e. computerized sequence generation)"
The weblink: http://www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data analysis will be performed using Microsoft Excel 2010 and Statistical Package for Social Science for Windows version 20.0 (SPSS, Inc, Chicago, IL). The number of colony forming units (CFU) for different microbial types, and the percentage of contact lens storage cases contaminated with various microbial species will be calculated, and compared to control lens cases. Log differences of case contamination will be summarized as mean +/- SD and compared with factors that may affect lens case contamination (from the questionnaires) using a univariate ANOVA. Bonferroni correction will use for post hoc multiple comparisons.

Recruitment
Recruitment status
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)
NSW
Recruitment postcode(s) [1] 17954 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 297919 0
University
Name [1] 297919 0
School of Optometry and Vision Science, University of New South Wales
Address [1] 297919 0
Level 3, Rupert Myers Building North wing,
School of Optometry and Vision Science, UNSW
Barker Street, Kingsford, Sydney, NSW-2052, Australia
Country [1] 297919 0
Australia
Primary sponsor type
University
Name
School of Optometry and Vision Science, University of New South Wales
Address
Level 3, Rupert Myers Building North wing,
School of Optometry and Vision Science, UNSW
Barker Street, Kingsford, Sydney, NSW-2052, Australia
Country
Australia
Secondary sponsor category [1] 296980 0
None
Name [1] 296980 0
Address [1] 296980 0
Country [1] 296980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298914 0
Human Research Ethics Committee, University of New South Wales
Ethics committee address [1] 298914 0
Level 3, Rupert Myers Building North Wing, School of Optometry and Vision Science, University of New South Wales, Kingsford, Sydney, Australia. NSW 2052
Ethics committee country [1] 298914 0
Australia
Date submitted for ethics approval [1] 298914 0
26/12/2016
Approval date [1] 298914 0
07/02/2017
Ethics approval number [1] 298914 0
HC16961

Summary
Brief summary
The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases.
This study is a prospective, randomized, double-masked, crossover clinical trial with three scheduled visits. A total 51 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for one month) along with a recommended multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand.
There will be total 3 visits within 2 months (baseline, 1st month and 2nd month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1st and 2nd month visits. At the end of 1st and 2nd month visits participants will be requested to complete a questionnaire relating to their contact lens use and we expect this activity will take approximately 20-30 minutes to complete.
The contact lens case and solution will be provided free of charge during the study and at the end of 3rd study visit when the last lens case will be collected a replacement contact lens case will be provided. Participants will be provided with a $10 vouchers on 2nd and 3rd visits to compensate for their costs incurred in attending the study visits.
Trial website
N/A
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 78634 0
Prof Fiona Stapleton
Address 78634 0
Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country 78634 0
Australia
Phone 78634 0
+61 2 9385 4375
Fax 78634 0
Email 78634 0
f.stapleton@unsw.edu.au
Contact person for public queries
Name 78635 0
Miss Ananya Datta
Address 78635 0
Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 78635 0
Australia
Phone 78635 0
+61 2 9385 4536
Fax 78635 0
Email 78635 0
ananya.datta@unsw.edu.au
Contact person for scientific queries
Name 78636 0
Miss Ananya Datta
Address 78636 0
Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 78636 0
Australia
Phone 78636 0
+61 2 9385 4536
Fax 78636 0
Email 78636 0
ananya.datta@unsw.edu.au

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