ANZCTR - Registration

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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]

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

Condition category

Condition code

Eye

Diseases / disorders of the eye

Infection

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]

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]

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]

1 month

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

19/06/2017

Date of last participant enrolment

Anticipated

8/12/2017

Actual

Date of last data collection

Anticipated

8/02/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Optometry and Vision Science, University of New South Wales

Address [1]

Level 3, Rupert Myers Building North wing,
School of Optometry and Vision Science, UNSW
Barker Street, Kingsford, Sydney, NSW-2052, Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, University of New South Wales

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

26/12/2016

Approval date [1]

07/02/2017

Ethics approval number [1]

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

Prof Fiona Stapleton

Address

Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 4375

Fax

f.stapleton@unsw.edu.au

Contact person for public queries

Name

Ananya Datta

Address

Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 4536

Fax

ananya.datta@unsw.edu.au

Contact person for scientific queries

Name

Ananya Datta

Address

Level 3, Rupert Myers Building, North Wing
SOVS, UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 2 9385 4536

Fax

ananya.datta@unsw.edu.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

Source	Title	Year of Publication	DOI
Embase	In vivo efficacy of silver-impregnated barrel contact lens storage cases.	2021	https://dx.doi.org/10.1016/j.clae.2020.08.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically