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Trial registered on ANZCTR


Registration number
ACTRN12623000337673
Ethics application status
Approved
Date submitted
17/03/2023
Date registered
31/03/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
31/03/2023
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of tear breakup time when wearing lipid-laden daily disposable contact lenses
Scientific title
Comparing comfort level after wearing lipid-laden contact lenses with control contact lenses (without lipids) and market contact lenses by assessing tear breakup time and tear lipid layer thickness among subjects with dry eyes who are experienced or new contact lens wearers
Secondary ID [1] 309234 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort 329388 0
Condition category
Condition code
Eye 326334 326334 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, tear break-up time, tear evaporation rate, and tear lipid layer thickness) of experienced and neophyte (new) contact lens wearers wearing lipid-laden contact lens (O-L), control contact lens (without lipids, C-L) and market contact lens (M-L).
In this study, participants will randomly (crossover study) wear lipid-imbibed lenses (O-L), control lenses that contain only small particles of surfactant with no LIPID (C-L), and normal commercially available contact lenses (M-L). The same lens will be worn in both eyes, all participants will wear all 3 lens types, and the lenses will be randomly assigned for wear.
Experienced or neophyte (new) contact lens wearers who meet the inclusion criteria will be enrolled in this single-site, randomized, crossover, double-masked prospective study.
At each visit (total 3 visits for three types of lenses + one visit for screening) the participant will wear (both the eyes same lens type) one of the study lenses (lipid [O-L], or Surfactant control [C-L], or Marketed lens [M-L]; for at least 8 hours. After 4-5 days (washout period), in the second visit, the second set of lenses will be worn in both eyes for at least 8 hours. In the third (last) visit (after 4-5 days) the remaining (last set of) lenses will be worn in both eyes for at least 8 hours.
In every visit (for all three types of lenses), before and after contact lens wear, the participant will be asked for Contact Lens Dry Eye Questionnaires-8 (CLDEQ) [not for neophyte wearers at their first visit as they will not be wearing lenses at that time and so will use the Dry Eye Questionnaires (DEQ-5)], subjectively rate the comfort of their eyes (on a 1 to 100 scale), and the following tests will be performed: Slit-Lamp Biomicroscopy to assess the health of ocular surface and eyelids, tear evaporation rate (TER), ocular surface staining, non-invasive tear breakup time, and tear lipid layer thickness.
Intervention code [1] 325674 0
Treatment: Devices
Comparator / control treatment
The control lens group will be commercially available contact lenses (M-L).
Control group
Active

Outcomes
Primary outcome [1] 334187 0
The primary endpoint is the changes in the tear break-up time of contact lens wearer over the 8 h of lens wear. Tear break-up time will be determined/quantified by Oculus Keratograph.
Timepoint [1] 334187 0
Baseline, after 1 h of lens wear, after 8 h of lens wear, and after removing contact lenses.
Primary outcome [2] 334274 0
The primary endpoint is the changes in the tear lipid layer thickness of contact lens wearer over the 8 h of lens wear. Tear lipid layer thickness will be determined/quantified by LipiView® Ocular Surface Interferometer.
Timepoint [2] 334274 0
Baseline, after 1 h of lens wear, after 8 h of lens wear, and after removing contact lenses.
Primary outcome [3] 334275 0
The primary endpoint is the changes in the tear evaporation rate of contact lens wearer over the 8 h of lens wear. Tear evaporation rate will be determined/quantified by VapoMeter (Delfin Technologies, Kuopio, Finland).
Timepoint [3] 334275 0
Baseline, after 1 h of lens wear, after 8 h of lens wear, and after removing contact lenses.
Secondary outcome [1] 419775 0
The endpoint are the changes in the ocular surface and eyelids (composite) of contact lens wearer over the 8 h of lens wear. The changes (in the ocular surface and eyelids) will be investigated by Slit-Lamp Biomicroscopy.
Timepoint [1] 419775 0
Baseline before wearing lenses, after 8 h of lens wear, and after removing contact lenses.
Secondary outcome [2] 420098 0
The endpoint is the changes in the ocular surface (staining test) of contact lens wearer after 8 h of contact lens wear. The changes in the ocular surface will be investigated by ocular surface staining.
Timepoint [2] 420098 0
Baseline before wearing lenses and after removing contact lenses.

Eligibility
Key inclusion criteria
• Between 18-40 years old
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Habitual contact lens wear and neophytes
• Refractive correction of -0.50 to -15.50, -0.25 to -1.75 and +0.50 to +1.75 diopters for myopia, astigmatism, and hyperopia
• Willing to wear the study contact lenses a minimum of 8 hours per day [in all three rounds].
• 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 for the duration of the study.
• Willing to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study
• Willing to undergo the tests as outlined in the information statement.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any active corneal infection, allergies
• Acute or sub-acute inflammation of the anterior chamber,
• 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 neurological disorders such as 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 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. computerised sequence 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
In this study, participants will randomly wear lipid-imbibed lenses (O-L), control lenses that contain only the small particles of surfactant with no lipid (C-L), and normal commercially available contact lenses (M-L). The same lens will be worn in both eyes, all participants will wear all 3 lens types [in total 7 visits, for 3 days (one type lens each day in both the eyes)], and the lenses will be randomly assigned for wear.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The plan is to enroll 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 tear break-up time over 8 h, we would require 20 peoples. This sample size would also allow us to detect effects for differences in the lipid layer thickness accounting for 10% dropouts and maintain constant power under conditions examined in this study.

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
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
26/07/2023
Date of last participant enrolment
Anticipated
30/09/2023
Actual
25/09/2023
Date of last data collection
Anticipated
31/10/2023
Actual
25/09/2023
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24304 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 39854 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 313423 0
University
Name [1] 313423 0
University of New South Wales
Country [1] 313423 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] 315188 0
None
Name [1] 315188 0
Address [1] 315188 0
Country [1] 315188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312636 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 312636 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052 NSW
Ethics committee country [1] 312636 0
Australia
Date submitted for ethics approval [1] 312636 0
31/03/2023
Approval date [1] 312636 0
26/05/2023
Ethics approval number [1] 312636 0
HC230193

Summary
Brief summary
Contact lens discomfort and its associated dryness are the primary reason to discontinue using contact lenses. In addition, users with decreased tear volume are more prone to be intolerant to soft contact lenses. The lipids of the tear film are produced in the meibomian gland in the eyelids and this lipid is delivered from the meibomian gland 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 stabilise and spread tears across the ocular surface and retard tear evaporation. The amount of lipids in tears is reduced in people with dry eye, and dry eye is related to contact lens comfort. 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 eye drops as more of the component remains on the eye.
We have produced lipids in the form of small particles that are stabilized using a surfactant compound, and shown that these can be imbedded into contact lenses. A small-scale study has shown that these lipid-containing contact lenses do not increase redness or other clinical measures associated with toxic responses. Now, we would like to test these lenses in a larger study and measure whether lens wearers can notice an improvement in symptoms during wear.
In this study, participants will randomly wear lipid-imbibed lenses (O-L), control lenses that contain only the small particles of surfactant with no lipid (C-L), and normal commercially available contact lenses (M-L). The same lens will be worn in both eyes, all participants will wear all 3 lens types (in total 7 visits), and the lenses will be randomly assigned for wear.
The primary endpoint is the changes in the tear break-up time, tear evaporation rate, and lipid layer thickness of contact lens wearer over the 8 h of lens wear. The secondary endpoint is the changes in the ocular surface and eyelids of the contact lens wearer over the 8 h of lens wear. The changes in the ocular surface will be investigated by corneal and conjunctival staining and Slit-Lamp Biomicroscopy.
The objectives will be a) to measure the comfort response of people wearing lipid-imbibed contact lenses (O-L) vs control lenses (C-L) vs commercially available contact lenses (M-L). b) to measure tear break-up time (tear stability) during contact lens wear of the lenses. c) to measure and evaluate tear lipid layer thickness during contact lens wear. d) to measure corneal and conjunctival staining after contact lens wear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125370 0
Prof Mark Willcox
Address 125370 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052,NSW
Country 125370 0
Australia
Phone 125370 0
+61409658313
Fax 125370 0
Email 125370 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 125371 0
Dr Furqan Maulvi
Address 125371 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052,NSW
Country 125371 0
Australia
Phone 125371 0
+61497182620
Fax 125371 0
Email 125371 0
f.maulvi@unsw.edu.au
Contact person for scientific queries
Name 125372 0
Dr Furqan Maulvi
Address 125372 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052,NSW
Country 125372 0
Australia
Phone 125372 0
+61497182620
Fax 125372 0
Email 125372 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.