Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001404213
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
21/08/2018
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Date results information initially provided
23/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Behavioral habits of contact lens wearers
Scientific title
The Effect of ‘No Water’ Packaging Stickers on the Behavior of Contact Lens Wearers
Secondary ID [1] 295785 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbial keratitis 309209 0
Acanthamoeba keratitis 309210 0
Contact lens related inflammatory keratitis 309308 0
Condition category
Condition code
Eye 308085 308085 0 0
Diseases / disorders of the eye
Public Health 308086 308086 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we propose to investigate the impact of contact lens (CL) packaging displaying a ‘no water’ logo/graphic and evaluate whether this affects wearers’ behaviours and attitudes to CL care/ wear. Two hundred established daily wear CL users will be recruited as study participants. CL wearers may use CL at their own discretion. Participants will be randomized to two groups, test and control. Test group will include those who will receive written instructions + “no water” graphic while control group will receive written instructions only. At baseline visit after being randomized, each research participant will receive a package which includes a pamphlet containing general instructions on safe CL use and one new CL case with or without a “No water” graphic sticker. The written instructions pamphlet has already been used in various publicity and awareness campaigns of School of Optometry and Vision Science, UNSW. The stickers will be attached on the top surface of the lid of CL storage case. Pre-made packs- some with stickers and some without will be given out randomly according to a randomization sequence. A masked investigator (PhD student) will deliver the packaging to each participant. At the follow up visit (six weeks interval), the participants will return their storage cases with/without the "no water" logo and will be given a replacement of storage case on conclusion of study. In order to track participants' CL wear schedule, they are asked specific questions regarding CL wearing routine at both baseline and follow up visits.
Intervention code [1] 312117 0
Behaviour
Intervention code [2] 312118 0
Treatment: Other
Comparator / control treatment
The control group will consist of CL wearers who will only receive written instructions pamphlet on safe contact lens wear along with a storage case without "no water"logo.
Control group
Active

Outcomes
Primary outcome [1] 307069 0
The primary outcome will be the change in water related hygiene behavior i.e water exposure of CL or storage case including using tap water while handling CLs/ clean CL storage case, showering or swimming while wearing CLs etc between test and control group after addition of CL packaging with/without a ‘no water’ logo graphic.
This change in water-related hygiene behavior will be assessed by a self-administered study specific questionnaire at bothe baseline and follow up visits.
Timepoint [1] 307069 0
At baseline and after 6 weeks interval
Secondary outcome [1] 350543 0
The secondary outcome will be the change in CL case contamination between test and control group after addition of CL packaging with/without "no water" logo graphic. The microbial analysis of CL storage cases will be conducted with ATP assay as well as Endotoxin assay to quantify overall contamination levels as well as Gram negative contamination.
Timepoint [1] 350543 0
At baseline and after 6 weeks interval

Eligibility
Key inclusion criteria
To be eligible to participate in this study;
1.CL wearers who are 18 years of age or older.
2. Using CL storage case.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specific exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of participants in test and control group will be conducted by using a pre-randomized "opaque sealed envelope" to provide study participants at baseline visit by a masked investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-made packs- some with "no water logo" and some without will be given out randomly according to a randomization sequence from "sealed envelope", an online randomization generator. (https://www.sealedenvelope.com/simple-randomiser/v1/lists) Blocked randomization technique is used to create the sequence of randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two hundred CL wearers will be randomized to either receive packaging with the ‘No water’ graphic or without.
It is known that rinsing of the CL storage case with tap water is a common source of exposure to Acanthamoeba spp. among even compliant CL wearers. CL wearers are attempting to “clean” their lens cases, but in doing so, they risk contamination with pathogens. Recent data suggests that around a third of asymptomatic CL wearers rinse their storage cases in tap water (35%). We assume that if behaviours such as showering in CL are included in this estimate, we would expect around 50% of asymptomatic lens wearers to have some contact with tap water. To detect a minimum odds ratio of 0.5x (relative precision of 30%), with a=0.05 and power of 80%, we would therefore require a sample size of 100 per group, i.e. 200 wearers in total (G*Power 3.1.9.2).
For data analysis: A general compliance score will be calculated out of a maximum of 40 (Lens disinfection 20, Hand hygiene 8, Case replacement 6, Case hygiene 6), based on previous study methodology. A water awareness score (maximum 15) and a water behaviour score (maximum 30) will also be generated.
Our primary endpoint is “behaviour change” at the 6 week time point and we will perform an ANCOVA to determine changes from baseline (non-normal data will be log transformed). “CL case contamination” change from baseline at 6 weeks will be secondary measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/06/2017
Date of last participant enrolment
Anticipated
31/10/2018
Actual
5/11/2018
Date of last data collection
Anticipated
15/11/2018
Actual
17/12/2018
Sample size
Target
200
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23685 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 300377 0
Commercial sector/Industry
Name [1] 300377 0
Alcon laboratories, Pty, Ltd.
Country [1] 300377 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Optometry and Vision Science, University of New South Wales, Barker street, Kensington, Sydney 2033, NSW. Australia.
Country
Australia
Secondary sponsor category [1] 299826 0
Individual
Name [1] 299826 0
Dr. Jacqueline Tan
Address [1] 299826 0
School of Optometry and Vision Science, University of New South Wales, Barker street, Kensington, Sydney 2033, NSW. Australia.
Country [1] 299826 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301187 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 301187 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 301187 0
Australia
Date submitted for ethics approval [1] 301187 0
31/08/2016
Approval date [1] 301187 0
26/10/2016
Ethics approval number [1] 301187 0
HC16735

Summary
Brief summary
Inappropriate water exposure can add to microbial contamination of the CL, storage case and cause sight threatening adverse events such as Acanthamoeba keratitis. In this study we propose to investigate the impact of CL packaging displaying a ‘no water’ logo graphic and evaluate whether this affects CL wearers’ behaviours and attitudes to CL care/ wear and the microbial contamination of the CL storage case. We hypothesize that inclusion of "no water"logo graphic will change CL wearer's behavior towards less water exposure during CL use and ultimately will lower the microbial contamination of CL storage case.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2965 2965 0 0
/AnzctrAttachments/375773-Project protocol.pdf (Protocol)
Attachments [2] 2966 2966 0 0
/AnzctrAttachments/375773-Participnat_information_sheet and consent-form.pdf (Participant information/consent)
Attachments [3] 2967 2967 0 0
/AnzctrAttachments/375773-Project approval by HREC.Pdf (Ethics approval)
Attachments [4] 2968 2968 0 0
/AnzctrAttachments/375773-Supplementory information No water logo for test group.pdf (Supplementary information)
Attachments [5] 2969 2969 0 0
/AnzctrAttachments/375773-Supplementory information Placebo intervention Scanned Pamphlet on written instructions (2).pdf (Supplementary information)
Attachments [6] 2997 2997 0 0
/AnzctrAttachments/375773-Baseline questionnaire.pdf (Supplementary information)
Attachments [7] 2998 2998 0 0
/AnzctrAttachments/375773-Follow up questionnaire.pdf (Supplementary information)

Contacts
Principal investigator
Name 86150 0
Dr Jacqueline Tan-Showyin
Address 86150 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86150 0
Australia
Phone 86150 0
+61 2 9385 6551
Fax 86150 0
Email 86150 0
[email protected]
Contact person for public queries
Name 86151 0
Ms Memoona Arshad
Address 86151 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86151 0
Australia
Phone 86151 0
+61 414 786 163
Fax 86151 0
Email 86151 0
[email protected]
Contact person for scientific queries
Name 86152 0
Ms Memoona Arshad
Address 86152 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86152 0
Australia
Phone 86152 0
+61 414 786 163
Fax 86152 0
Email 86152 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
The final data analysis is underway and we hope to provide the IPDs after submission and approval of thesis, subject to university's policies, as UNSW holds the proprietary rights for this data.


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
SourceTitleYear of PublicationDOI
EmbaseCompliance behaviour change in contact lens wearers: a randomised controlled trial.2021https://dx.doi.org/10.1038/s41433-020-1015-9
N.B. These documents automatically identified may not have been verified by the study sponsor.