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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Contact lens related discomfort

Condition category

Condition code

Eye

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]

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]

Non-invasive tear breakup time

Timepoint [1]

Baseline and after 8 hours of lens wear

Secondary outcome [1]

Subjective comfort

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

School of Optometry and Vision Science - Kensington

Recruitment postcode(s) [1]

2033 - Kensington

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

CooperVision, Inc.

Address [1]

Country [1]

United States of America

Primary sponsor type

University

Name

University of New South Wales

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of New South Wales Research Ethics Committee A

Ethics committee address [1]

https://research.unsw.edu.au/research-ethics-and-compliance-support-recs

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/06/2024

Approval date [1]

Ethics approval number [1]

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

Prof Mark Willcox

Address

Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW

Country

Australia

Phone

+61409658313

Fax

[email protected]

Contact person for public queries

Name

A/Prof. Jacqueline Tan-Showyin

Address

Eye Research Group, Rupert Myers Building, North wing Gate 14, Barker Street, School of Optometry and Vision Science, UNSW, Kensington, NSW, 2052

Country

Australia

Phone

+610293856551

Fax

[email protected]

Contact person for scientific queries

Name

Dr. Furqan Maulvi

Address

Level 3, Rupert Myers Building, North wing Gate 14, Barker Street UNSW Sydney 2052, NSW

Country

Australia

Phone

+61497182620

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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