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Trial registered on ANZCTR


Registration number
ACTRN12619001520123
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
4/11/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
4/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How effective are anti-bacterial contact lens storage cases?
Scientific title
3-month study of microbial contamination of silver contact lens storage cases in daily wear frequent replacement soft contact lens wearers.
Secondary ID [1] 299631 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Storage Case Contamination 314949 0
Condition category
Condition code
Eye 313297 313297 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Silver-impregnated antimicrobial contact lens storage cases (Test) and HyCare multipurpose disinfecting solution (MPDS) manufactured by CooperVision, CA, USA will be used. Participants will use the lens storage cases and MPDS for a total of 3 months. The order in which participants will be exposed to the test and control contact lens storage cases will be randomised. Contact lens storage case will used for 1 month and returned at the 1-month (1 case) and 3-month (2 cases) follow-up visit. Participants will be provided with labelled sealable plastic bags to store their 1-month used contact lens storage cases and MPDS bottles. Participants will be required to start using a new pair of their habitual contact lenses at commencement of the study. They will have to wear their contact lenses for at least 4 days a week on average for the duration of the study and to replace their contact lenses according to the manufacturer’s recommended schedule. Participants will be advised to wash and dry their hands with soap prior to handling contact lenses and storage cases. Following contact lens removal from the eye, participants will be advised to place clean the lenses with the HyCare MPDS (rub both sides of the lens with the MPDS using their forefinger and rinse with MPDS) and place the lenses directly into the appropriate lens case wells pre-filled with the HyCare MPDS. The lens case wells will then be capped, and lenses left overnight or for a minimum period of 4 hours (the manufacturer’s recommended minimum disinfection and cleaning time) to disinfect them. On removal of the contact lenses from the case after disinfection, participants will be required to rinse their lenses with the HyCare MPDS before placing them on their eyes. The participants will be asked to discard the remaining MPDS solution in the lens storage case wells, rinse the wells and lids thoroughly with fresh HyCare MPDS solution and to air dry the storage cases. Participants will be asked to return their used bottle of HyCare MPDS at the scheduled one-month (1 bottle) and three month (2 bottles) follow-up visits. These used MPDS bottles will be weighed to monitor participant compliance with use. The participants will be crossed over to use the control contact lens storage cases (without silver) for the following 3 months at the next visit without any washout.
Intervention code [1] 315890 0
Treatment: Devices
Comparator / control treatment
Contact lens storage cases without silver (Control) of the same shape and design of the experimental silver lens cases and HyCare multipurpose disinfecting solution (MPDS) manufactured by CooperVision, CA, USA will be used. Participants will use the lens storage cases and MPDS for a total of 3 months. The order in which participants will be exposed to the test and control contact lens storage cases will be randomised. Contact lens storage case will used for 1 month and returned at the 1-month (1 case) and 3-month (2 cases) follow-up visit. Participants will be provided with labelled sealable plastic bags to store their 1-month used contact lens storage cases and MPDS bottles. Participants will be required to start using a new pair of their habitual contact lenses at commencement of the study. They will have to wear their contact lenses for at least 4 days a week on average for the duration of the study and to replace their contact lenses according to the manufacturer’s recommended schedule. Participants will be advised to wash and dry their hands with soap prior to handling contact lenses and storage cases. Following contact lens removal from the eye, participants will be advised to place clean the lenses with the HyCare MPDS (rub both sides of the lens with the MPDS using their forefinger and rinse with MPDS) and place the lenses directly into the appropriate lens case wells pre-filled with the HyCare MPDS. The lens case wells will then be capped, and lenses left overnight or for a minimum period of 4 hours (the manufacturer’s recommended minimum disinfection and cleaning time) to disinfect them. On removal of the contact lenses from the case after disinfection, participants will be required to rinse their lenses with the HyCare MPDS before placing them on their eyes. The participants will be asked to discard the remaining MPDS solution in the lens storage case wells, rinse the wells and lids thoroughly with fresh HyCare MPDS solution and to air dry the storage cases. Participants will be asked to return their used bottle of HyCare MPDS at the scheduled one-month (1 bottle) and three month (2 bottles) follow-up visits. These used MPDS bottles will be weighed to monitor participant compliance with use. The participants will be crossed over to use the test contact lens storage cases (with silver) for the following 3 months at the next visit without any washout period.
Control group
Active

Outcomes
Primary outcome [1] 321778 0
Comparison of the proportion (percentage) of silver (test) and non-silver (control) contact lens storage cases contamined with bacteria. One-month used contact lens storage cases will be sent to the microbiology laboratory within one hour of collection. An unmasked researcher will swab the lens case wells using a sterile cotton swab and culture the bacteria using standard microbial culture techniques.
Timepoint [1] 321778 0
Visit 1: Baseline
Visit 2: 1 months after Visit 1
Visit 3: 2 months after Visit 2
Visit 4: 1 month after Visit 3
Visit 5: 2 months after Visit 4
Primary outcome [2] 321838 0
To identify the types of micro-organisms recovered from silver-impregnated (test) and non-silver (control) contact lens storage cases. Following bacterial culture of the contact lens storage case wells, bacteria will be identified using standard biochemical methods.
Timepoint [2] 321838 0
Visit 1: Baseline
Visit 2: 1 months after Visit 1
Visit 3: 2 months after Visit 2
Visit 4: 1 month after Visit 3
Visit 5: 2 months after Visit 4
Secondary outcome [1] 376431 0
None
Timepoint [1] 376431 0
None

Eligibility
Key inclusion criteria
1. Age 18 years or older at the time of screening.
2. Be a current frequent replacement soft contact lens wearer (hydrogel or silicone hydrogel)
3. Be willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week for the duration of the study and follow standard contact lens practice and precautions during lens wear
4. Be willing to use the study prescribed contact lens cleaning and disinfection solution and lens storage case for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Daily disposable or extended wear soft contact lens wearer
2. Rigid gas permeable lens wearer (including orthokeratology).
3. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
4. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
5. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
6. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
8. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
9. Be currently pregnant or breastfeeding

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304107 0
Commercial sector/Industry
Name [1] 304107 0
CooperVision Inc
Country [1] 304107 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CooperVision Inc
Address
6150 Stoneridge Mall Road #370
Pleasanton,
CA 94588, USA
Country
United States of America
Secondary sponsor category [1] 304323 0
None
Name [1] 304323 0
None
Address [1] 304323 0
None
Country [1] 304323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304597 0
Human Research Ethics Committee, University of New South Wales, Sydney
Ethics committee address [1] 304597 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] 304597 0
Australia
Date submitted for ethics approval [1] 304597 0
28/10/2019
Approval date [1] 304597 0
19/12/2019
Ethics approval number [1] 304597 0

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, single-masked, crossover clinical trial with five scheduled visits. A total 40 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for three month) along with a multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand.
There will be total 5 visits within 6 months (baseline, 1 month, 3 months, 4 month and 6 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 1, 3, 4 and 6 month visits. At each visit, participants will be requested to complete two questionnaires relating to their contact lens use. The contact lens storage cases and multi-purpose disinfecting solutions will be provided free of charge during the duration of the study. Participants will be provided with a $10 vouchers at the end of each study visit to compensate for their costs incurred in attending the study visits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97522 0
Dr Ajay Kumar Vijay
Address 97522 0
Level 3, Rupert Myers Building North Wing, School of Optometry and Vision Science, University of New South Wales, Kingsford, Sydney, Australia. NSW 2052
Country 97522 0
Australia
Phone 97522 0
+61 0293854503
Fax 97522 0
Email 97522 0
[email protected]
Contact person for public queries
Name 97523 0
Ajay Kumar Vijay
Address 97523 0
Level 3, Rupert Myers Building North Wing, School of Optometry and Vision Science, University of New South Wales, Kingsford, Sydney, Australia. NSW 2052
Country 97523 0
Australia
Phone 97523 0
+61 0293854503
Fax 97523 0
Email 97523 0
[email protected]
Contact person for scientific queries
Name 97524 0
Ajay Kumar Vijay
Address 97524 0
Level 3, Rupert Myers Building North Wing, School of Optometry and Vision Science, University of New South Wales, Kingsford, Sydney, Australia. NSW 2052
Country 97524 0
Australia
Phone 97524 0
+61 0293854503
Fax 97524 0
Email 97524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5459Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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