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Trial registered on ANZCTR


Registration number
ACTRN12619000240145p
Ethics application status
Submitted, not yet approved
Date submitted
14/02/2019
Date registered
18/02/2019
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Intense Pulsed Light in Contact Lens Discomfort
Scientific title
The Role of Intense Pulsed Light in Contact Lens Discomfort Among Contact Lens Wearers with Meibomian Gland Dysfunction
Secondary ID [1] 297361 0
SOVS-74
Universal Trial Number (UTN)
U1111-1228-3084
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens discomfort 311528 0
Meibomian gland dysfunction 311529 0
Condition category
Condition code
Eye 310164 310164 0 0
Normal eye development and function
Eye 310165 310165 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment that the participants will receive is administered from a device known as Eye-Light. This device is an intense pulsed light treatment. The Eye-Light treatment will be administered by the co-investigator, a vision science honours student who has been taught the correct method by the company who provided the device. This treatment does not require the use of ultrasound gel during the procedure. The Eye-Light works within the visible light spectra of 600nm. The intensity will be determined based on the pigment of the participant's skin using the Fitzpatrick grading scale. The participant's Fitzpatrick category will be determined by placing the Eye-Light on the participant's skin. After the participant has been categorised, the device will give an intensity output that will be suitable for the level of pigment the participant has. The intensity varies between 25-65 J/cm2. The treatment will be performed individually to each participant in person, face to face in a clinical room at the School of Optometry and Vision Science, UNSW. It will be performed according to the manufacturer's set requirement. The device will emit 5 flashes of light to the skin below the lower eyelids. Each eye will receive the 5 flashes of light from the nasal to temporal region below the participant's lower eyelid. This procedure will take approximately 5 minutes for both eyes. Both the participant and investigator will wear light protection goggles during the procedure. The participant will receive this treatment 4 times, over the span of 45-days with approximately 15 days between each visit. Each visit will take approximately 1.5 hours.
Intervention code [1] 313636 0
Treatment: Devices
Comparator / control treatment
The control treatment utilises the Eye-Light machine, however the flash of light will be directed towards the ceiling rather than onto the participant's skin. The device will still make contact with the skin whilst the lamp faces upwards, to ensure that the participant does not know what treatment they are receiving .
Control group
Placebo

Outcomes
Primary outcome [1] 319050 0
Changes in comfort scores assessed with CLDEQ-8 score
Timepoint [1] 319050 0
Following final treatment of intense pulsed light i.e. 60 days after initial treatment
Primary outcome [2] 319051 0
Changes in Meibomian gland structure assessed with Oculus Keratograph and in vivo confocal microscopy
Timepoint [2] 319051 0
60 days after initial treatment
Secondary outcome [1] 366827 0
Change in lipid layer thickness assessed with LipiView Interferometer
Timepoint [1] 366827 0
60 days after initial treatment
Secondary outcome [2] 366828 0
Assess changes in tear film with Oculus Keratograph
Timepoint [2] 366828 0
60 days after initial treatment
Secondary outcome [3] 366829 0
Assess corneal morphology with confocal microscopy
Timepoint [3] 366829 0
60 days after initial treatment

Eligibility
Key inclusion criteria
- Over 18 years of age
- Current contact lens wearers with contact lens discomfort
- Evidence of Meibomian gland obstruction (evidenced by a Meibomian gland secretion score of <12 for 15 glands of the lower lid)
- CLDEQ-8 score greater than or equal to 12
- Fitzpatrick skin type 1-4
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ocular medication, category S3 and above
- Any systemic or topical medications that will affect ocular physiology or the performance of the lenses e.g. anti-acne medications such as Roaccutane and corticosteroids or immunosuppressant medications such as Hydrocortisone, Prednisolone
- Any systemic disease that may affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension do not automatically exclude prospective subjects
- Eye surgery within 12 weeks immediately prior to enrolment for this trial
- Previous corneal refractive surgery
- Patients with punctal plugs
- Patients who tanned in the last 4 weeks
- Patients with skin cancer or pigment lesions in the treatment zone
- Pregnant or nursing patients

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)
Randomisation is decided via a web-based randomisation system. This occurs after the patient is deemed eligible for the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is decided via a web-based randomisation system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is calculated based on a meaningful difference of 3 points on the CLDEQ-8 with a standard deviation of 5 points for 95% confidence and 80% power, indicating 36 participants in each group. To account for attrition, 40 participants will be recruited for each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
Date of last participant enrolment
Anticipated
18/07/2019
Actual
Date of last data collection
Anticipated
18/09/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301966 0
University
Name [1] 301966 0
UNSW School of Optometry and Vision Science
Country [1] 301966 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 301682 0
None
Name [1] 301682 0
N/A
Address [1] 301682 0
N/A
Country [1] 301682 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302610 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 302610 0
Ethics committee country [1] 302610 0
Australia
Date submitted for ethics approval [1] 302610 0
15/02/2019
Approval date [1] 302610 0
Ethics approval number [1] 302610 0

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

Contacts
Principal investigator
Name 90814 0
Dr Maria Markoulli
Address 90814 0
Level 3, North Wing, RMB
Gate 14, Barker Street
The University of New South Wales
Sydney NSW 2052
Country 90814 0
Australia
Phone 90814 0
+61 2 9385 9229
Fax 90814 0
Email 90814 0
m.markoulli@unsw.edu.au
Contact person for public queries
Name 90815 0
Nivaasheni Chandramohan
Address 90815 0
Rupert Myers Building
Gate 14, Barker Street
The University of New South Wales
Sydney NSW 2052
Country 90815 0
Australia
Phone 90815 0
+61 2 9385 9229
Fax 90815 0
Email 90815 0
z3463979@unsw.edu.au
Contact person for scientific queries
Name 90816 0
Nivaasheni Chandramohan
Address 90816 0
Rupert Myers Building
Gate 14, Barker Street
The University of New South Wales
Sydney NSW 2052
Country 90816 0
Australia
Phone 90816 0
+61 2 9385 9229
Fax 90816 0
Email 90816 0
z3463979@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
Data will be stored at the UNSW School of Optometry and Vision Science. The school does not allow for participants' data to be publicly available.


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.