Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000762550p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2024
Date registered
21/06/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of tear stability and comfort when wearing oil-laden daily disposable contact lenses
Scientific title
Assessment of tear stability and comfort response when wearing (O-acyl)-hydroxy fatty acids laden daily disposable contact lenses in habitual contact lens wearers aged 18-45 years
Secondary ID [1] 312297 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens related discomfort 334029 0
Condition category
Condition code
Eye 330700 330700 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It’s a crossover trial, in which three different contact lenses will be evaluated: (i) Comfilcon A contact lenses with (O-acyl)-hydroxy fatty acids and surfactant (ii) Comfilcon A contact lenses with surfactant only, and (iii) the marketed Comfilcon A contact lenses will act as the control. There will be a 24-hour washout period between treatments. The lens power (strength) will range from -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power). A record book/attendance sheet will be used to monitor adherence or fidelity to the intervention. The same lens type will be worn in both eyes and the order of lens wear will be randomly assigned. All participants will wear each lens type on a single occasion for approximately 8 hours.
Intervention code [1] 328760 0
Treatment: Devices
Comparator / control treatment
The control lens group will be commercially available Comfilcon A contact lenses (M-L).
Control group
Active

Outcomes
Primary outcome [1] 338454 0
Non-invasive tear breakup time
Timepoint [1] 338454 0
Baseline and after 8 hours of lens wear
Secondary outcome [1] 436013 0
Subjective comfort
Timepoint [1] 436013 0
Baseline, and after 4 hours and 8 hours of lens wear

Eligibility
Key inclusion criteria
• Aged 18-45 years old (inclusive)
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Habitual contact lens wearer
• Spherical refractive error between -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power)
• Able to achieve a minimum 6/9.5 binocular visual acuity while wearing the study lenses (with over-spectacles if required)
• Willing to wear the study contact lenses for a minimum of 8 hours per day.
• Willing to refrain from wearing their habitual contact lenses for a minimum of 24 hours prior to each visit
• Have health and ocular health findings which would not prevent the participant from safely wearing contact lenses
• Willing to not use any rewetting eye drops on the morning of study visits and while wearing the study contact lenses
• Willing to refrain from swimming, showering, and/or sleeping while wearing the study contact lenses
• Willing to undergo the tests as outlined in the information statement.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Gas permeable contact lens wearer
• Any active corneal infection, ocular allergies
• Recent or short-term inflammation in the front part of the eye
• Pregnancy (or planning pregnancy), lactating/breast feeding, suffering from the systemic diseases Sjögren’s syndrome, rheumatoid arthritis, systemic lupus erythematosus, diabetes and thyroid eye disease or taking the medications atropine, antazoline, azatadine or antihistamines such as cetirizine, brompheniramine
• People who have undergone refractive surgery
• People with epilepsy

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)
The participant wearing the lenses and clinician who will be assess the ocular surface will be masked tothe lenses being worn. The method of allocation concealment will be numbered containers.
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. computerisedsequence generation)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants who complete the study will be included in the analysis dataset. Data analysis will be performed using SPSS 22.0 (SPSS Inc., Chicago, IL). Clinical variables will be classified as parametric or nonparametric after testing for normality using the Shapiro-Wilk test. Data will be summarised as means ± standard deviations for variables measured on an interval scale and median ± inter-quartile range for ordinal variables. Multifactorial analysis of variance (ANOVA) will be compared the mean/median differences of variables between baseline and follow-up visits. The p value is set at p < 0.05. Bonferroni adjustment will be used for multiple comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26661 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 42701 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 316686 0
Commercial sector/Industry
Name [1] 316686 0
CooperVision, Inc.
Country [1] 316686 0
United States of America
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 318877 0
None
Name [1] 318877 0
Address [1] 318877 0
Country [1] 318877 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315463 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 315463 0
https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
Ethics committee country [1] 315463 0
Australia
Date submitted for ethics approval [1] 315463 0
04/06/2024
Approval date [1] 315463 0
Ethics approval number [1] 315463 0

Summary
Brief summary
Contact lens discomfort and its associated dryness are the primary reasons to discontinue using contact lenses. In addition, users with decreased tear volume are more prone to be intolerant to soft contact lenses. The lipids (oils) of the tear film are produced in the meibomian glands in the eyelids, and these lipids are delivered from the meibomian glands to the eye to form part of the tear film lipid layer. This layer promotes tear film stability and prevents drying of the ocular surface. Several of these lipids help stabilize and spread tears across the ocular surface and retard tear evaporation. The amount of lipids in tears is reduced in people with dry eyes, and dry eye is related to contact lens discomfort. Contact lens discomfort is worse when people's meibomian glands are blocked. Therefore, we hypothesize that adding lipids back to the eye during contact lens wear will help form a stable tear film and reduce dry eye sensations. We and many others have shown that delivering components from contact lenses is preferable to delivering by eyedrops as more of the component remains on the eye.
The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and comfort level) of experienced contact lens wearers wearing oil-loaded contact lenses. This study was designed as a single-center, double-masked, randomized study. At the baseline visit, experienced contact lens wearers who meet the inclusion criteria will be enrolled in the study. After baseline, participants will be asked to attend the clinic on three different days with two visits per day (morning and evening). The same lens will be worn in both eyes, all participants will wear all three lens types (in total, three visits), and the lenses will be randomly assigned for wear.
Participants will randomly wear oil-imbibed lenses (O-L), control lenses that contain only small particles of surfactant with no oil (C-L), and normal commercially available contact lenses (M-L). The primary endpoint is the changes in the tear break-up time of contact lens wearers over the 8 hours of lens wear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134782 0
Prof Mark Willcox
Address 134782 0
Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW
Country 134782 0
Australia
Phone 134782 0
+61409658313
Fax 134782 0
Email 134782 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 134783 0
A/Prof. Jacqueline Tan-Showyin
Address 134783 0
Eye Research Group, Rupert Myers Building, North wing Gate 14, Barker Street, School of Optometry and Vision Science, UNSW, Kensington, NSW, 2052
Country 134783 0
Australia
Phone 134783 0
+610293856551
Fax 134783 0
Email 134783 0
Jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 134784 0
Dr. Furqan Maulvi
Address 134784 0
Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW
Country 134784 0
Australia
Phone 134784 0
+61497182620
Fax 134784 0
Email 134784 0
f.maulvi@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.