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Trial registered on ANZCTR


Registration number
ACTRN12620000761965p
Ethics application status
Submitted, not yet approved
Date submitted
18/05/2020
Date registered
27/07/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the role of conjunctival and lid margin sensitivity has in ocular discomfort
Scientific title
To investigate the sensitivity of the conjunctiva and lid margin to cold stimuli and determine the repeatability of sensitivity measurement using the Liquid Jet Aesthesiometer (LJA)
Secondary ID [1] 301322 0
Nil known
Universal Trial Number (UTN)
U1111-1252-2135
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular discomfort 317522 0
Condition category
Condition code
Eye 315618 315618 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Air Jet Stimulation of the Conjunctiva and Lid Margin
Brief Description: Different parts of the eyes have different sensitivities and contribute to ocular discomfort in different ways. By using a machine which causes air jet stimulation of certain sites of the eye, the sensitivity of the structure can be determined and linked to the level of ocular discomfort they experience.
The machine is attached to a slit lamp bio-microscope where a subject places their chin and forehead onto the attached rest. The participant is instructed to look a target in the room and the machine is manoeuvred and aimed at the appropriate site of the eye.
Duration of observation: Each test to measure sensitivity will span approximately 10 minutes. With multiple repeats at different ocular sites, the time needed to complete the observation will be approximately 2.5 hours. There will be 1 repeat on the cornea, 3 repeats on the bulbar conjunctiva and 1 repeat on the lid margins. The session will be conducted and administered by final year optometry students under the supervision of A/Prof Blanka Golebiowski, Adj Professor Klaus Ehrmann and Professor Fiona Stapleton.
Intervention code [1] 317718 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323853 0
To investigate the sensitivity of the conjunctiva to cold stimuli using the LJA to detect via a staircase method whether a variety of stimuli at different intensities can be felt. The participant can indicate if a particular intensity is felt by clicking a provided button.
Timepoint [1] 323853 0
At the completion of the observation session
Primary outcome [2] 323968 0
Determine the repeatability of sensitivity measurement using the LJA.
At the end of each scheduled visit, the Liquid Jet Aesthesiometer will provide us with quantitative threshold data that will be statistically analysed once all data has been collected. The paired sample t-test is used to determine whether the mean difference between the two samples are zero, and therefore determine whether the measurements with the LJA when a cold stimulus is repeatable.
Timepoint [2] 323968 0
At the completion of the observation session with all participants
Primary outcome [3] 324237 0
To investigate the sensitivity of the lid margin to cold stimuli using the LJA to detect via a staircase method whether a variety of stimuli at different intensities can be felt. The participant can indicate if a particular intensity is felt by clicking a provided button.
Timepoint [3] 324237 0
At the completion of the observation session
Secondary outcome [1] 383053 0
Ocular discomfort as measured by the Ocular Surface Disease Index, Ocular Comfort Index and the Instant Ocular Symptoms Survey. These are all in the form of questionnaires.
Timepoint [1] 383053 0
At the completion of the observation session

Eligibility
Key inclusion criteria
18 to 40 years old
Able to read and comprehend English
Either a full-time soft contact lens wearer or do not wear contact lenses
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have any eye or general health conditions which may affect your eyes, for example severe dry eye, active eye allergy, Graves’ disease, diabetes, Sjögren syndrome or multiple sclerosis
Have any eye infections or inflammation
Currently use eye and/or general medication which is known to affect eye health or eye comfort, such as chloramphenicol, prednisolone acetate, Accutane, antidepressant medications, topical glaucoma drops or anti-allergy drops
Have any history of eye surgery like corneal refractive surgery or cataract surgery
Wear soft contact lenses overnight or on an intermittent or part-time basis only
Are a current or previous wearer of hard contact lenses, including Ortho-K lenses
Are pregnant or breastfeeding

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The instrumentation is designed to reach a threshold value using a programmed double staircase method and data will be collected using the software linked to the LJA. The data will have to be processed manually by inputting the values collected by the software into an Excel spreadsheet for subsequent analysis. Subsequent analysis will involve grouping independent and/or dependent variables appropriately and entering said data into data analysis and graphing software such as SPSS. Through SPSS, the repeatability of the machine can be determined, it can compare values from the conjunctiva and lid margin and examine if sex or contact lens wear influences ocular discomfort. A two-way analysis of variance (ANOVA) will be used to detect differences in threshold between different ocular sites and the Bonferroni Post Hoc Test will be used to determine between group (CL vs non-CL lens) groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30305 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 305759 0
University
Name [1] 305759 0
UNSW Australia
Address [1] 305759 0
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country [1] 305759 0
Australia
Primary sponsor type
University
Name
UNSW Australia
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 306194 0
None
Name [1] 306194 0
Address [1] 306194 0
Country [1] 306194 0
Other collaborator category [1] 281319 0
Individual
Name [1] 281319 0
Blanka Golebiowski
Address [1] 281319 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country [1] 281319 0
Australia
Other collaborator category [2] 281320 0
Individual
Name [2] 281320 0
Fiona Stapleton
Address [2] 281320 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country [2] 281320 0
Australia
Other collaborator category [3] 281321 0
Individual
Name [3] 281321 0
Anne Chung
Address [3] 281321 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country [3] 281321 0
Australia
Other collaborator category [4] 281322 0
Individual
Name [4] 281322 0
Klaus Ehrmann
Address [4] 281322 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country [4] 281322 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306031 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 306031 0
UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 306031 0
Australia
Date submitted for ethics approval [1] 306031 0
08/04/2020
Approval date [1] 306031 0
Ethics approval number [1] 306031 0

Summary
Brief summary
The research study aims to investigate the sensitivity of the eyelid margin and the conjunctiva (a thin layer on the white part of your eye) using an instrument called the Liquid Jet aesthesiometer, which uses small drops of saline to stimulate your eye. Participants will be invited to take part in this study to help us better understand what the role the conjunctiva and lid margin have in eye discomfort, and to analyse the repeatability of this new instrument.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102486 0
A/Prof Blanka Golebiowski
Address 102486 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country 102486 0
Australia
Phone 102486 0
+612 9385 4502
Fax 102486 0
+61 2 9313 6243
Email 102486 0
b.golebiowski@unsw.edu.au
Contact person for public queries
Name 102487 0
A/Prof Blanka Golebiowski
Address 102487 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country 102487 0
Australia
Phone 102487 0
+612 9385 4502
Fax 102487 0
+61 2 9313 6243
Email 102487 0
b.golebiowski@unsw.edu.au
Contact person for scientific queries
Name 102488 0
A/Prof Blanka Golebiowski
Address 102488 0
Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
Country 102488 0
Australia
Phone 102488 0
+612 9385 4502
Fax 102488 0
+61 2 9313 6243
Email 102488 0
b.golebiowski@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 not be publicly available with consent from participants only allowing for data to be available to researchers in future studies.
What supporting documents are/will be available?
No other documents available
Summary results
No Results