Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001252606p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2023
Date registered
4/12/2023
Date last updated
4/12/2023
Date data sharing statement initially provided
4/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of new contact lens disinfectant solution on the contact lens discomfort
Scientific title
The investigation of the effect of new contact lens disinfectant solution to the symptoms of contact lens discomfort in participants who have been wearing contact lenses for at least 6 months
Secondary ID [1] 308668 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contatct lens discomfort 331969 0
Condition category
Condition code
Eye 328701 328701 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 effect of contact lens disinfectant 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 over a 12 weeks (at least 6-8 hours, 5 days a week), changing their lenses every four weeks, a commonly recommended wear schedule.
Participants also will be asked to use a new contact lens disinfectant made by 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 contact lens disinfectants at the first visit, and participants are then asked to have a clinical examination and sample collection at the clinic four times: at the first visit, 4 weeks later (visit #2), 8 weeks later (visit #3) and 12 weeks later (visit #4).The first visit will take about 90 minutes and the second and subsequent visits take about 60 minutes.
All the Interventions including examinations and instructions are performed by trained investigator, including optometrists and Japanese ophthalmologists.In addition, there are no plans to monitor adherence to the intervention.
Intervention code [1] 327340 0
Treatment: Drugs
Intervention code [2] 327536 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336511 0
The primary outcome is the changes in dynamics of tear fluid on the ocular surface.
These are assessed by slit-lamp biomicroscope and meibography by analysing the blinking behaviour.
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] 336511 0
Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.
Primary timepoint will be 84 days
Primary outcome [2] 336636 0
Ocular surface will be evaluated by slit-lamp biomicroscope
Timepoint [2] 336636 0
Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.
Primary timepoint will be 84 days
Secondary outcome [1] 429124 0
Contact lens dry eye questionnaires-8 (CLDEQ) will be used to evaluate the discomfortable during contact lens wear
Timepoint [1] 429124 0
Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.
secondary timepoint will be 84 days

Eligibility
Key inclusion criteria
• Be at least 18 years of age,
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• 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 (12 weeks),
• 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.
• Willing to undergo the tests outlined in the section 3 of this form.
• Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13.
• Have health and ocular health, defined as no fluorescein after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after instillation, considering minimal staining of grade 1 as normal in contact lens wearers.
• Normal corrected vision, defined as a minimum of 20/40 best corrected visual acuity in each eye.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any active corneal infection, allergies, and Acute or sub-acute inflammation of the anterior chamber.
• Severe insufficiency of lacrimal secretion (dry eye, less than or equal to 10mm for Phenol red thread test at Baseline).
• Any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines,
• People who have undergone corneal refractive surgery and neurological disorder such as epilepsy.
• 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).

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
Efficacy
Statistical methods / analysis
Sample size required in order to detect a change over time was calculated assuming alpha of 0.05 and 95% power.
To detect a small effect size for meibomian gland expression over 12 weeks we would require 24 people and finally, 30 subjects were considered as the required number of subjects to account for dropouts. This sample size would also allow us to detect effects for differences in the noninvasive tear break-up time, CLEDQ-8 score tear break up time, and expression of meibomian gland under conditions examined in this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
24/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25809 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 41636 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312901 0
University
Name [1] 312901 0
University of New South Wales
Country [1] 312901 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] 314579 0
None
Name [1] 314579 0
Address [1] 314579 0
Country [1] 314579 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312176 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 312176 0
Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052 NSW
Ethics committee country [1] 312176 0
Australia
Date submitted for ethics approval [1] 312176 0
21/11/2023
Approval date [1] 312176 0
Ethics approval number [1] 312176 0

Summary
Brief summary
The aim of this study is to evaluate the impact of contact lens disinfectant on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 12-week, changing their lenses every four weeks, a commonly recommended wear schedule and use a new contact lens disinfectant made by Ophtecs Corp (Japan).
• The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first four weeks of lens wear using a new lens care product.
• The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123742 0
A/Prof Mark Willcox
Address 123742 0
School of Optometry and Vision Science, Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052,NSW
Country 123742 0
Australia
Phone 123742 0
+61 409658313
Fax 123742 0
Email 123742 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 123743 0
Dr Motophiro Itoi
Address 123743 0
School of Optometry and Vision Science Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW
Country 123743 0
Australia
Phone 123743 0
+61 423634371
Fax 123743 0
Email 123743 0
m.itoi@unsw.edu.au
Contact person for scientific queries
Name 123744 0
Dr Motophiro Itoi
Address 123744 0
School of Optometry and Vision Science Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW
Country 123744 0
Australia
Phone 123744 0
+61 423634371
Fax 123744 0
Email 123744 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.