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Trial registered on ANZCTR


Registration number
ACTRN12624000744550p
Ethics application status
Submitted, not yet approved
Date submitted
30/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of lipid loaded daily disposable contact lenses on tear film break up
Scientific title
Comparing the tear film stability and comfort level during wear of lipid loaded daily disposable contact lenses in experienced contact lens wearers
Secondary ID [1] 312193 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
contact lens related discomfort 333861 0
Condition category
Condition code
Eye 330537 330537 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the research is to investigate changes in the surface of your eyes whilst you are wearing daily disposable soft contact lenses embedded with (O-acyl)-hydroxy fatty acids (OAHFA) and Wax Esters(WE) and compare the effect with marketed commercially available contact lenses.
Single center, double masked, randomised study. Three contact lens materials (Comfilcon A, Somofilcon A , and Nesofilcon A) are included in the study, these materials compositions are different, two are silicone hydrogels (comfilcon A, and somofilcon A) and one hydrogel (nesofilcon A). These three contact lens materials loaded with two types of lipids (OAHFA and WE). The loaded six contact lenses types and three commercially available lenses (i.e total nine different types of lenses) are randomised and will be assessed the ocular surface changes in nine study days.
,At the baseline visit, experience contact lens wearers who meet the inclusion criteria will be enrolled in the study by trained optometrist ( he will be the responsible for administering the intervention). after baseline, participant will be asked to attend the clinic on nine different study days with two visits per day (morning and evening).Participants will also be advised not to wear their habitual contact lenses for 24 hours (they can use spectacles instead) prior to each visit, to ensure that there is no potential impact on the eyes from their regular contact lens use. Participants will be asked to schedule their study visits with a minimum 48 hours between morning visits or maximum of seven days between visits (i.e., wash out period). At each visit, the participant will have the health of their eyes confirmed and then wear one of the randomly allocated study lenses for at least 8 hours in both eyes, and after 8 hours of lens wear, we will be assessed the clinical procedures at all visits.
We will be maintaining the participant attendance sheet for all visits, and monitoring regularly during the study duration period.
This study will be conducted at Eye Research Group clinic suites, School of optometry and vision science, University of New South Wales, Sydney.
Intervention code [1] 328643 0
Treatment: Devices
Comparator / control treatment
The control group will be three commercially available contact lenses (not embedded with OAHFA and WE lipids), those are comfilcon A, somofilcon A, and nesofilcon A contact lens materials. they are different in composition's,first two, comfilcon A and somofilcon A are silicone hydrogels and nesofilcon A is hydrogel materials.
Participant will be wearing the control group lenses also 8 hours.
Control group
Active

Outcomes
Primary outcome [1] 338305 0
The primary outcome is to evaluate the non-invasive tear breakup time when wearing lipid loaded daily disposable contact lenses
Timepoint [1] 338305 0
Baseline,and after 8 hours of lens wear on nine separate study days
Secondary outcome [1] 435373 0
The secondary outcome is to evaluate the comfort score when wearing lipid loaded daily disposable contact lenses.
Timepoint [1] 435373 0
Baseline, at after 15 minutes,4 hours and 8 hours of lens wear on nine separate study days .
Secondary outcome [2] 436068 0
The secondary outcome is to evaluate the corneal staining when wearing lipid loaded daily disposable contact lenses
Timepoint [2] 436068 0
baseline,and after 8hours of lens wear on 9 separate study days
Secondary outcome [3] 436069 0
The secondary outcome is to evaluate the tear film lipid layer thickness when wearing lipid loaded daily disposable contact lenses
Timepoint [3] 436069 0
Baseline,and after 8 hours of lens wear on nine separate study days
Secondary outcome [4] 436391 0
The secondary outcome is to evaluate the conjunctiva staining when wearing lipid loaded daily disposable contact lenses
Timepoint [4] 436391 0
Baseline, and after 8 hours of lens wear on nine separate study days

Eligibility
Key inclusion criteria
•Aged 18-65 years old (inclusive)
•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Experience contact lens wearers.
•Refractive correction of -0.50DS to -10.00DS or +0.50 to +1.75DS (inclusive), with <1.00DC (cylinder power) (to ensure contact lens powers available to provide adequate vision correction).
•Willing to wear the study contact lenses for approx. 8 hours per day [at all nine visits].
Have health and ocular health findings which would not prevent you from safely wearing contact lenses.
•Willing to not use any rewetting eye drops for the during study lens wearing days.
•Willing to refrain from swimming, showering and/or sleeping while wearing the study 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
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Any active corneal infection or allergies
•Any inflammation of the surface 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 surgery on the front part of the eye
•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)
Central randomization by computer (online)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
1/11/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26569 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 42611 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 316568 0
University
Name [1] 316568 0
University of New South Wales
Country [1] 316568 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 318746 0
None
Name [1] 318746 0
Address [1] 318746 0
Country [1] 318746 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315355 0
The University of New South Wales Committee C
Ethics committee address [1] 315355 0
Ethics committee country [1] 315355 0
Australia
Date submitted for ethics approval [1] 315355 0
30/05/2024
Approval date [1] 315355 0
Ethics approval number [1] 315355 0

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

Contacts
Principal investigator
Name 134438 0
Prof Mark Willcox
Address 134438 0
Level 3, Rupert Myers Building, North wing Gate 14, Barker street , UNSW, Sydney, NSW, 2052
Country 134438 0
Australia
Phone 134438 0
+61409658313
Fax 134438 0
Email 134438 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 134439 0
Srikanth Dumpati
Address 134439 0
Level 3, Ruperts Myers Building, North wing Gate 14, Barker street, UNSW, Sydney, NSW, 2052
Country 134439 0
Australia
Phone 134439 0
+61 450858653
Fax 134439 0
Email 134439 0
s.dumpati@unsw.edu.au
Contact person for scientific queries
Name 134440 0
Srikanth Dumpati
Address 134440 0
Level 3, Ruperts Myers Building, North wing Gate 14, Barker street, UNSW, Sydney, NSW, 2052
Country 134440 0
Australia
Phone 134440 0
+61 450858653
Fax 134440 0
Email 134440 0
s.dumpati@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.