Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000064606
Ethics application status
Approved
Date submitted
2/01/2023
Date registered
18/01/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
18/01/2023
Date results provided
20/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of new contact lens disinfectants on Contact Lens Discomfort
Scientific title
Investigation of the effect of contact lens disinfectants on signs and symptoms of contact lens discomfort in adult daily contact lens wearers
Secondary ID [1] 308669 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contatct lens discomfort
 328594 0
Condition category
Condition code
Eye 325608 325608 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear.
We will ask participants to wear Comfilcon A contact lenses at least 5 days per week for at least 6 hours per day, wearing the same lenses for 2 weeks and then replaced with new lenses every 2 weeks, as a commonly recommended wear schedule.
Participants also will be asked to use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) containing polyhexamethylene biguanide hydrochloride and Alexidine dihydrochloride as the main ingredients in the following manner: Every day after lens removal, gently rub and wash both sides of the lens with the disinfectant 20-30 times per side and soak the lens in the disinfectant for at least 4 hours or over nights. In addition, before wearing the lenses, participants will rinse them with the disinfectant for at least 5 seconds before starting to wear them.
The eligible subjects will be provided with lenses and disinfectants and will be instructed cleaning/disinfection procedures at the first visit, and participants are then asked to have a clinical examination and sample collection for a total of one hour each time at the clinic three times: at the first visit, 3 weeks later (visit #2), and 6 weeks later (visit #3) with each visit lasting a total of approximately one hour.
Clinical examinations include visual acuity test, slit-lamp biomicroscopy with corneal and conjunctival staining, phenol red thread test, contact lens dry eye questionnaire, tear volume, noninvasive tear fluid layer thickness, meibography, and noninvasive tear fluid layer thickness measurement.
All the Interventions including examinations and instructions are performed by trained investigator, including optometrists and Japanese ophthalmologists.
Intervention code [1] 325153 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333466 0
Changes in ocular physiology, expressed as a composite of changes in the ocular surface including meibomian glands and tears.
Ocular surface will be evaluated by slit-lamp biomicroscope and meibography.
.
Timepoint [1] 333466 0
Base line, 21 days, 42 days after using daily disposable contact lenses and new lens care product.
Primary timepoint will be 42 days
Secondary outcome [1] 417189 0
Contact lens dry eye questionnaires-8 (CLDEQ) will be used to evaluate the discomfortable during contact lens wear
Timepoint [1] 417189 0
Base line, 21 days, 42 days after using daily disposable contact lenses and new lens care product.
Secondary outcome [2] 417651 0
Ocular surface will be evaluated by slit-lamp biomicroscope and meibography
Timepoint [2] 417651 0
Base line, 21 days, 42 days after using daily disposable contact lenses and new lens care product.

Eligibility
Key inclusion criteria
• Aged 18 years or above
• Willing to sign informed consent and comply with study schedule
• Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on daily wear modality, where the lenses are worn for at least 6hours per day and remove the lenses before sleep.
• Willing to wear their lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study (6 weeks), and to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
• Willing to not use any rewetting eye drops for the duration of the study and to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study
• No noticeable scarring of the ocular surface that should avoid CL wear (no grade 2 or higher staining as a result of a single drop of nonconservative fluorescein solution and examination 1 minute after the drop).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any ocular or systemic disease that might influence the tear film or ability to safely wear contact lenses.
• Any history of previous ocular surgery or trauma, including chalazion exclusion, oculoplastic surgery.
• Be pregnant, planning to become pregnant during the 6 weeks of the study or be lactating (any participant that does become pregnant during the study should inform the study personnel immediately so that they can be withdrawn from the study since the increased level of hormones can impact ocular comfort during lens wear).
• Current use of any prescription on non-prescription ocular or systemic medications, including antihistamines.
• Would be likely to use artificial tear preparations during the period 4 hours before all visits. Use of any ocular ointment during the 3 days before all visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The plan is to enrol 20 subjects to complete the trial. Sample size required in order to detect a change over time was calculated assuming alpha of 0.05 and 80% power. To detect a small effect size for meibomian gland secretion over six weeks we would require 20 people (please see the table below). This sample size would also allow us to detect effects for differences in the noninvasive tear break-up time accounting for 10% dropouts and maintain constant power under conditions examined in this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2023
Actual
14/06/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
4/10/2023
Date of last data collection
Anticipated
11/08/2023
Actual
30/11/2023
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23758 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 39203 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312902 0
University
Name [1] 312902 0
University of New South Wales
Country [1] 312902 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052, NSW
Country
Australia
Secondary sponsor category [1] 314580 0
None
Name [1] 314580 0
Address [1] 314580 0
Country [1] 314580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312177 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 312177 0
Ethics committee country [1] 312177 0
Australia
Date submitted for ethics approval [1] 312177 0
06/02/2023
Approval date [1] 312177 0
27/03/2023
Ethics approval number [1] 312177 0
HC230059

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

Contacts
Principal investigator
Name 123746 0
A/Prof Mark Willcox
Address 123746 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052,NSW
Country 123746 0
Australia
Phone 123746 0
+61 409658313
Fax 123746 0
Email 123746 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 123747 0
Motophiro Itoi
Address 123747 0
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052, NSW
Country 123747 0
Australia
Phone 123747 0
+61 423634371
Fax 123747 0
Email 123747 0
m.itoi@unsw.edu.au
Contact person for scientific queries
Name 123748 0
Motophiro Itoi
Address 123748 0
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052, NSW
Country 123748 0
Australia
Phone 123748 0
+61 423634371
Fax 123748 0
Email 123748 0
m.itoi@unsw.edu.au

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?

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.