Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001543774p
Ethics application status
Submitted, not yet approved
Date submitted
21/11/2022
Date registered
13/12/2022
Date last updated
13/12/2022
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Contact lens comfort with daily disposable contact lens
Scientific title
Comparison of ocular response, comfort, and corneal curvature during daily disposable silicone hydrogel contact lens wear in healthy eyes

Secondary ID [1] 308453 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Daily disposable contact lens discomfort 328254 0
Condition category
Condition code
Eye 325298 325298 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 of experienced and neophyte (new) contact lens wearers wearing three different types of daily disposable contact lenses.
We will ask participants to use three types of daily disposable contact lenses which are made of different polymers called Somofilcon A, Verofilcon A, and Narafilcon A. Types of lenses will be randomly allocated.
Participants will be asked to wear the contact lenses in both eyes on a daily disposable basis for 30(±3) days, for a minimum of 6 hours per day at least 5 days per week and instructed not to sleep in their lenses.
Participants will be asked to not wear any contact lenses 18-24 hours before wearing the next set of lenses and 24 hours between each type (washout period).
This process will be repeated for all three lens types investigated in this study and each period will be separated by 18-24h. At the next three follow-up visits, different brands of daily disposable contact lenses will be provided to the participants. Lens prescription and clinical assessments will be performed by an optometrist.
Participants will be provided one opaque manila envelope at V2 to V4 to bring the foil covers of the worn lenses’ packages in the next visit (this is to ensure that all the lenses were worn by the participants).
Intervention code [1] 324897 0
Diagnosis / Prognosis
Intervention code [2] 324941 0
Treatment: Devices
Comparator / control treatment
No Control group; this is a direct comparison between three different contact lenses
Verofilcon A is a highly breathable silicone hydrogel contact lens material, with a Dk/t 35°C of 100×10-11 (cm2/sec) (mL O2/mL × mmHg). Verofilcon A lenses has 51% water content.
Control group
Active

Outcomes
Primary outcome [1] 333162 0
The primary outcome is to compare the comfort of three different contact lenses when worn on a daily disposable (i.e. new lens worn every day) basis.
The contact lens dry eye questionnaire-8 (CLDEQ-8) will be used to assess the comfort of lenses during wear
Timepoint [1] 333162 0
The CLDEQ-8 questionnaire will be administered at baseline, 4 days, 32 days (primary timepoint), 60 days, and 88 days after using daily disposable contact lenses.
Secondary outcome [1] 416008 0
The Pittsburgh sleep quality assessment (PSQI) will be used to assess sleep disturbance
Timepoint [1] 416008 0
The secondary outcome will be measured at baseline, 4 days, 32 days (secondary timepoint), 60 days, and 88 days after using daily disposable contact lenses.
Secondary outcome [2] 416201 0
An optical coherence tomography instrument will be used to determine corneal thickness
Timepoint [2] 416201 0
The secondary outcome [2] will be evaluated baseline, 4 days, 32 days (secondary timepoint [2]), 60 days, and 88 days after using daily disposable 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 6 hours per day at least 5 days per week for the duration of the study
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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
• Any active corneal infection, allergies
Acute or sub-acute inflammation of the anterior chamber,
Pregnancy (or planning pregnancy), lactating/breast feeding, and any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines,
People who have undergone refractive surgery
People with neurological disorders such as epilepsy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
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
1/02/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23589 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 39009 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312697 0
University
Name [1] 312697 0
University of New South Wales
Country [1] 312697 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] 314312 0
None
Name [1] 314312 0
Address [1] 314312 0
Country [1] 314312 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311997 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 311997 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052 NSW
Ethics committee country [1] 311997 0
Australia
Date submitted for ethics approval [1] 311997 0
21/11/2022
Approval date [1] 311997 0
Ethics approval number [1] 311997 0

Summary
Brief summary
Contact lens discomfort or dryness is the primary reason to discontinue using soft contact lenses.
Contact lens users with decreased tear volume are more intolerant to lenses (but not tested with daily disposable lenses). Contact lens materials, replacement schedules and care regimens may affect corneal structure and tear physiology . There is an increase in ocular discomfort at end of the day (but there is a paucity of information for daily disposable lens wearers).
We have found that Dailies Total 1 has greater comfort than Acuvue TruEye (unpublished data). Also, transferring people to Dailies Total 1 was associated subjects being reclassified as asymptomatic. However, the reason for this change has not been identified.
Meibomian glands are oil-producing glands in the eyelids. Their dysfunction is a primary cause of dry eye. Changes in the quality and composition of their oily secretions (meibum) cause tear film instability which might lead to discomfort and dryness during lens wear.
Sphingolipids are components of the meibum that play an important role in inflammation. In tears, sphingolipid composition is correlated with tear production and dry eye symptoms in non-contact lens wearers..There are no studies on this relationship during contact lens wear.
Somatosensory dysfunction (such as stress and anxiety) may cause dry eyes in the absence of any clinical changes to the ocular structure or tear film.. We have anecdotally noted a relationship between cornea thickness and comfort. This study will determine whether this anecdotal observation can be reproduced by scientific evaluation.
The primary outcome is change in physicochemical changes in the tear film
To correlate changes in tear film and meibomian gland structure and composition to comfort during contact lens wear.
Secondary Outcomes
To investigate the relationship between discomfort during lens wear with sleep disturbance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123114 0
Prof Mark Willcox
Address 123114 0
Prof Mark Willcox
School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052,NSW
Country 123114 0
Australia
Phone 123114 0
+61409658313
Fax 123114 0
Email 123114 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 123115 0
Mr Mukesh Kumar
Address 123115 0

School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052, NSW
Country 123115 0
Australia
Phone 123115 0
+61423055428
Fax 123115 0
Email 123115 0
mukesh.kumar1@unsw.edu.au
Contact person for scientific queries
Name 123116 0
Mr Mukesh Kumar
Address 123116 0

School of Optometry and Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street
UNSW Sydney
2052, NSW
Country 123116 0
Australia
Phone 123116 0
+61423055428
Fax 123116 0
Email 123116 0
mukesh.kumar1@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.