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Trial registered on ANZCTR


Registration number
ACTRN12622001346763p
Ethics application status
Not yet submitted
Date submitted
10/10/2022
Date registered
19/10/2022
Date last updated
19/10/2022
Date data sharing statement initially provided
19/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Intense Pulsed light therapy improve the signs and symptoms of contact lens discomfort
Scientific title
Investigation of the effect of Intense Pulsed Light therapy on the signs and symptoms of contact lens discomfort.
Secondary ID [1] 308099 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens related discomfort 327780 0
Condition category
Condition code
Eye 324851 324851 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the research is to measure qualitative and quantitative differences in signs and symptoms of contact lens discomfort following Intense Pulsed Light (IPL) therapy.
IPL treatment will be delivered with a handpiece held by the investigator.

In this trial we will be using Intense Pulsed light (IPL) treatment for contact lens discomfort. The IPL emits light wavelength ranges from 515 to 1200 nm. A 560-nm filter will be adjusting for appropriate setting (range of 11–14 J/cm2) to a specific participant, trained optometrists (unmasked investigator) determines the skin type, and adjust the IPL settings according to the skin type and the condition to treat. Before the treatment begins, both eyes must be protected with goggles or disposable eye patches, and a thin layer of transparent gel must be spread on the treatment area . This treatment will be given on periocular are surrounding the eyelids on each eye 30 shots for the duration of 5mins.This procedure will be conducted on two visits, baseline and following after 3weeks visit (1st follow up visit) to the participants and the procedure will conducted at Eye Research Group clinic suites, School of optometry and Vision Science, University of New South Wales, Sydney.
Intervention code [1] 324537 0
Treatment: Devices
Comparator / control treatment
Control group - Sham treatment
Sham treatment group follow the same protocol with the exception that the IPL device will not be activated.
This treatment will be given on periocular are surrounding the eyelids on each eye 30 shots for the duration of 5mins.This procedure will be conducted on two visits, baseline and following after 3weeks visit (1st follow up visit) to the participants similar to interventional group.
Control group
Placebo

Outcomes
Primary outcome [1] 332668 0
The primary outcome is change in Contact lens dry eye questionnaire -8 (CLDEQ-8) symptoms score following Intense pulsed light therapy in contact lens wearers
Timepoint [1] 332668 0
base line, 21days and 42 days post intervention commencement
Secondary outcome [1] 414327 0
The secondary outcome is change the Tear break up time after intense pulsed light therapy in contact lens wearers.
Timepoint [1] 414327 0
base line, 21days, 42days post intervention commencement
Secondary outcome [2] 414496 0
The secondary outcomes is change the Meibomian gland expression after intense pulsed light therapy in contact lens wearers
Timepoint [2] 414496 0
base line, 21days, 42days post intervention commencement

Eligibility
Key inclusion criteria
•Age of 18 years and above
•Willing to sign informed consent and comply with study schedule.
•Normal vision defined as a minimum of 20/40 best corrected visual acuity in each eye.
•Healthy ocular surface, defined as no fluorescein corneal staining of grade 2 or more after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after installation, considering minimal staining of grade 1 as normal in contact lens wearers.
•Normal external ocular examination with no eyelid deformation
•Ability to cooperate with and undergo the required study procedures.
•Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on a daily wear modality, where the lenses are worn for at least of 6 hours per day and remove the lenses before sleep.
•Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Any ocular or systemic disease that might influence the tear film
•All forms of conjunctivitis, including allergic conjunctivitis
•Any history of previous ocular surgery or trauma, including chalazion excision, oculoplastic
surgery.
•History of eyelid and periorbital skin disease or allergies in the past 1 month.
•History of herpes zoster infection and any viral infection episode before.
•Pregnancy, breast feeding
•Skin cancer, user of photosensitive drugs /foods
•Dark or deeply pigmented skin (Skin Fitzpatrick scale V/VI), which can be prone skin
damage, such as discoloration or scarring after IPL treatment.
•Current use of any prescription on nonprescription ocular or systemic medications, including antihistamines.
•Use of artificial tear preparations during the period 4 hours before all visits
•Use of any ocular ointment during the 3 days before any study visit.
•Have an history of epilepsy and migraine
•Have any history of previous IPL treatment for dry eye.

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 randomisation 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants who complete the study treatment will be included in the analysis dataset. Data analysis will be performed using SPSS 22.0(SPSS Inc., Chicago, IL). Clinical markers 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 a interval scale and median± inter-quartile range for ordinal variables. Multifactorial analysis of variance will be compared the mean/median differences of variables with each of the two treatments 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
1/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 38645 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 312345 0
University
Name [1] 312345 0
University of New South Wales
Country [1] 312345 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
NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 313907 0
None
Name [1] 313907 0
Address [1] 313907 0
Country [1] 313907 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311708 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 311708 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street,
UNSW Sydney
NSW 2052
Australia
Ethics committee country [1] 311708 0
Australia
Date submitted for ethics approval [1] 311708 0
24/10/2022
Approval date [1] 311708 0
Ethics approval number [1] 311708 0

Summary
Brief summary
Approximately 150 million people wear contact lenses (CL) globally . Of these, 50% experience discomfort during contact lens wear and 25% of wearers are likely to discontinue wear permanently. The etiology of contact lens discomfort (CLD) is multifactorial and could be due to reduced compatibility between CL and the ocular environment. Intense Pulsed light therapy has been proven to be an effective therapy for improvement of signs and symptoms of dry eye disease, but it has not been fully evaluated as a treatment for contact lens discomfort.
This project aims to evaluate the qualitative and quantitative change in signs and symptoms of Contact lens discomfort (CLD) and Meibomian gland dysfunction (MGD) following Intense Pulsed Light (IPL) treatment in Contact lens wearers.
The research hypotheses is that Intense pulsed light (IPL) therapy will improve the signs and symptoms of CLD and MGD in contact lens wearers.
This study designed as single centre, randomised, double masked trial, and consists of three visits. At the first visit, screening will be performed to determine the eligibility to take part in the study, If eligible, various clinical procedures will be conducted, followed by random allocation to one of the two treatments (Intense pulsed light or sham treatment) with Meibomian gland expression.
The primary outcome is an improvement in Contact lens dry eye questionnaire -8 (CLDEQ-8) symptoms score following Intense pulsed light therapy in contact lens wearers.
The secondary outcome is an improvement in tear break up time and Meibomian gland expression following intense pulsed light therapy in contact lens wearers
.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122078 0
Prof Mark Duncan Willcox
Address 122078 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street,
UNSW Sydney
NSW 2052
Australia
Country 122078 0
Australia
Phone 122078 0
+61409658313
Fax 122078 0
Email 122078 0
[email protected]
Contact person for public queries
Name 122079 0
Srikanth Dumpati
Address 122079 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street,
UNSW Sydney
NSW 2052
Australia
Country 122079 0
Australia
Phone 122079 0
+61450858653
Fax 122079 0
Email 122079 0
[email protected]
Contact person for scientific queries
Name 122080 0
Srikanth Dumpati
Address 122080 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker Street,
UNSW Sydney
NSW 2052
Australia
Country 122080 0
Australia
Phone 122080 0
+61450858653
Fax 122080 0
Email 122080 0
[email protected]

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.