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Trial registered on ANZCTR


Registration number
ACTRN12623001224617
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
28/11/2023
Date last updated
28/11/2023
Date data sharing statement initially provided
28/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Tackling tear film instability in contact lens wear
Scientific title
Crossover trial comparing the impact of over-the-counter tear supplements with and without lipid components on tear film quality before and after contact lens wear in habitual soft contact lens wearers
Secondary ID [1] 310603 0
None
Universal Trial Number (UTN)
Trial acronym
TFiS-CL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort 331483 0
Condition category
Condition code
Eye 328486 328486 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Topically applied tear film supplements

Dose administered: A masked investigator would administer one drop/spray applied as a single application to each eye, on the day of examination 10 minutes before contact lenses are worn. Each participant will be tested for all of the interventions with one intervention randomly assigned per visit for a total of 3 intervention visits and 1 control visit. On each visit the participants will be asked to wear CL for no more than 30 minutes. The CL lenses will be discarded at end of each visit.

All the interventions used in this study are over-the-counter products commercially available in New Zealand and include two types of lubricating eye drops (Systane Ultra and Systane Complete, Alcon), one type of lubricating eye spray (Tears Again, Eye Spray, BioRevive) and one type of soft daily disposable silicone hydrogel contact lens (MyDay, Cooper Vision).

All test visits will be scheduled within 2 weeks from enrollment and there will be a minimum washout period of 24 hours between the test visits.
Intervention code [1] 327179 0
Treatment: Drugs
Comparator / control treatment
Placebo

Visit with contact lenses but without application of any lubricating eye drops will serve as a control visit. This will be achieved by having an unmasked investigator pretending to install a drop from an empty bottle.
Control group
Placebo

Outcomes
Primary outcome [1] 336304 0
Lipid layer grade (LLG) as assessed subjectively by a masked investigator from interferometric videos captured by the Oculus Keratograph 5M.
Timepoint [1] 336304 0
Measurements will be recorded at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.

Primary Timepoint: final assessment of each daily visit will be 10 minutes after contact lenses are inserted.

Assessment will be performed at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.
Secondary outcome [1] 427782 0
Change in non-invasive tear breakup time (NIKBUT)

Assessment method: Measured objectively using automated software within the Oculus Keratograph 5M
Timepoint [1] 427782 0
Assessment will be performed at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.
Secondary outcome [2] 427965 0
Change in lipid layer thickness (LLT)

Assessment method: Measured objectively by the Johnson & Johnson TearScience Lipiview
Timepoint [2] 427965 0
Assessment will be performed at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.
Secondary outcome [3] 427967 0
Change in tear meniscus height (TMH)

Assessment method: Measured using digital calipers from an image collected with the Oculus Keratograph
Timepoint [3] 427967 0
Assessment will be performed at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.
Secondary outcome [4] 428382 0
Changes in the tear evaporation rate

Assessment method: Measured objectively using Delfin Eye-Vapo meter
Timepoint [4] 428382 0
Assessment will be performed at baseline, 10 minutes after application of treatment or placebo (no drops/spray application) and again 10 minutes after contact lenses are inserted.

Eligibility
Key inclusion criteria
- 18 years or older
- Habitual soft CL wearer (of at least 1 month prior to study enrolment)
- Willing and able to follow the protocol accurately and to attend four study visits within a two week period
- Willing to not wear CL or apply any eye drops within 12 hours of the test visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Active ocular allergies
- Ocular surgery or dermatological treatments in the previous three months or planned during the study period
- Current or planned pregnancy or lactation during the study
- History of major systemic or ocular conditions

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)
Allocation is not concealed as all participants will undergo assessment with all intervention and one control
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will undergo four assessment visits, including one with each of the three interventions and one with no-intervention in this study. The sequence of theses visits will be randomized. Randomisation sequence for all interventions or no-intervention visits of this study [Systane Complete (lubricating eye drops with lipid), Systane Ultra (lubricating eye drops without lipid), and TearsAgain (lubricating eye spray with lipids)] will be derived by computer-generated random number allocation prior to the study and will be applied to participants by an unmasked investigator. The masked investigator will collect the study data. The randomisation schedule will be pre-determined, advance of study start, and applied consecutively to enrolled participants, So that neither masked or unmasked investigators have any influence in treatment allocation.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: 34

Justification:
Sample size requirements were determined from non-parametric adjusted power calculations conducted using NCSS PASS 2002 (Utah, USA), with lipid layer grade as the designated outcome, and the standard deviation estimated to be approximately 1 grade. The power calculation showed that a minimum of 34 participants is required to detect a clinically significant difference of 1 lipid layer grade, with 80% power (ß equal 0.2), at a two-sided statistical significance level of 5% (a equal 0.05). Allowing for a 10% participant dropout rate or loss to follow-up by the 3rd visit, requiring a total of 38 participants to be recruited.

Statistical Analysis:
The difference between treatment outcomes will be assessed using repeated measures two-way analysis of variance (ANOVA) for continuous variables with normal distributions confirmed by Kolmogorov-Smirnov testing (p > 0.05). Non-normally distributed continuous and ordinal data will be converted to rank-values prior to undergoing analysis. Categorical data (treatment satisfaction) will be compared using Fisher's exact test. All tests will be two-tailed and p less than 0.05 considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/12/2023
Actual
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
29/05/2024
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 25887 0
New Zealand
State/province [1] 25887 0
Auckland

Funding & Sponsors
Funding source category [1] 314816 0
University
Name [1] 314816 0
University of Auckland
Country [1] 314816 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 316805 0
None
Name [1] 316805 0
Address [1] 316805 0
Country [1] 316805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313821 0
The Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 313821 0
The University of Auckland Private Bag 92019 Auckland 1142
Ethics committee country [1] 313821 0
New Zealand
Date submitted for ethics approval [1] 313821 0
Approval date [1] 313821 0
13/09/2023
Ethics approval number [1] 313821 0
AH26619

Summary
Brief summary
Background: Contact lenses (CLs) are a popular choice for correcting refractive error, offering freedom from spectacles and improving quality of life for wearers but they destabilise the tear film overlying the ocular surface, risking ocular surface desiccation and discomfort symptoms for the wearer. Topical artificial tear supplements are the recommended treatment for patients with dryness symptoms, with or without CLs, and are available in a range of modalities, with and without lipid components. The behaviour of the eyedrops in the presence of a CL differs from that in the non-CL wearing eye but has been poorly characterised. Understanding the interactions between CLs and different drop modalities is critical to ensuring patients are offered sound, evidence-based advice. This study seeks to address the gap in knowledge by evaluating the impact of drop modalities with and without lipid components on tear film stability both in the presence of CL wear and without.

Objectives: To evaluate the relative short-term effects on the pre-ocular and pre-lens tear film quantity and quality (its non-invasive tear film break-up time, tear meniscus height, lipid layer grade, lipid layer thickness and tear evaporation rate) following application of lubricating eye drops or eye spray.

Study Design: Prospective, randomised, investigator-masked, controlled clinical trial (for n=38 participants with or without symptoms of dry eye.

Study hypothesis: The lipid layer grade will be higher with instillation of a lipid drop than an aqueous drop, following application of a contact lens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129454 0
Prof Jennifer P. Craig
Address 129454 0
Department of Ophthalmology, The University of Auckland Private Bag 92019, Auckland, 1142
Country 129454 0
New Zealand
Phone 129454 0
+64 099238173
Fax 129454 0
Email 129454 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 129455 0
Prof Jennifer P. Craig
Address 129455 0
Department of Ophthalmology, The University of Auckland Private Bag 92019, Auckland, 1142
Country 129455 0
New Zealand
Phone 129455 0
+64 099238173
Fax 129455 0
Email 129455 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 129456 0
Prof Jennifer P Craig
Address 129456 0
Department of Ophthalmology, The University of Auckland Private Bag 92019, Auckland, 1142
Country 129456 0
New Zealand
Phone 129456 0
+64 099238173
Fax 129456 0
Email 129456 0
jp.craig@auckland.ac.nz

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20636Ethical approval    386599-(Uploaded-11-10-2023-10-34-51)-Study-related document.pdf



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.