Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001275459
Ethics application status
Approved
Date submitted
7/09/2016
Date registered
12/09/2016
Date last updated
15/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of Liquid Jet Aesthesiometer
Scientific title
Repeatability of a Liquid Jet Aesthesiometer and its application in contact
lens related comfort
Secondary ID [1] 290104 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal Sensitivity 300196 0
Ocular Comfort 300197 0
Condition category
Condition code
Eye 300079 300079 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study. The study consists of two stages. In the first stage, corneal sensitivity will be measured using the liquid jet aesthesiometer in participants over 5 days at similar time points over the 5 days. The liquid jet aesthesiometer uses tiny droplets of saline of variable size to generate a mechanical stimulus on the cornea without inducing a thermal component. Using a staircase method, participants will respond with a can or can't feel response to determine corneal sensitivity threshold.
In the second stage, corneal sensitivity and subjective ocular comfort ratings will be collected in the morning and afternoon (2 visits separated 6 hours apart) over 3 separate days. Ocular comfort ratings will be collected via a questionnaire prior to corneal sensitivity measurements using the Liquid Jet Aesthesiometer.
Intervention code [1] 295867 0
Not applicable
Comparator / control treatment
There is no control treatment in this study. In Stage 2, we will be comparing corneal sensitivity and ocular comfort ratings in participants who are soft contact lens wearers compared to those who are not.
Control group
Active

Outcomes
Primary outcome [1] 299572 0
To assess the repeatability of a Liquid Jet Aesthesiometer
Timepoint [1] 299572 0
Repeatability of the Liquid Jet Aesthesiometer will be assessed via measurements conducted at the same time over 5 separate days.
Secondary outcome [1] 327578 0
To assess the correlation between corneal sensitivity measurements and subjective ocular comfort in soft contact lens wearers and non-lens wearers. Corneal sensitivity measurements will be assessed using the Liquid Jet Aesthesiometer. Subjective ocular comfort will be assessed through questionnaires designed specifically for this study.
Timepoint [1] 327578 0
Correlation between corneal sensitivity and ocular comfort will be assessed between morning and afternoon measurements (6 hours apart) over 3 separate days.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old, male or female.
Willing to comply with the clinical trial visit schedule as directed by the Investigator.
Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
Be experienced soft contact lens wearers or inexperienced with contact lenses.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would affect corneal sensitivity.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Previous rigid gas permeable (RGP) or Orthokeratology lens wear
Currently enrolled in another clinical trial.
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Corneal sensitivity threshold will be recorded on an interval scale and summarised as means +/- standard deviations. Corneal sensitivity will be compared between five repeated days using repeated measures ANOVA or linear mixed model. The effect of contact lens wearers and its interaction with repeatability will also be assessed in this model.
Subjective ocular comfort will be recorded on a scale of 1 to 100 in increments of 1 unit. Ocular comfort and corneal sensitivity will be compared between time of day (morning vs. evening), contact lens wearers and repeat days. Ocular comfort and corneal sensitivity will be analysed using repeated measures ANOVA or linear mixed model. The correlation of corneal sensitivity with ocular comfort will be analysed using Pearson correlation and also assessed as a covariate in the model that includes time of day,

Approximately 15 soft contact lens wearers and 15 non-lens wearers are required for this study (adjusted for a 20% dropout rate). This was based on calculations on pre-clinical data, to demonstrate a statistically significant difference at the 5% level of significance and 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
22/11/2016
Date of last participant enrolment
Anticipated
Actual
16/12/2016
Date of last data collection
Anticipated
Actual
21/12/2016
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294492 0
Other
Name [1] 294492 0
Brien Holden Vision Institute
Country [1] 294492 0
Australia
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 293354 0
None
Name [1] 293354 0
Address [1] 293354 0
Country [1] 293354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295925 0
Bellberry Limited
Ethics committee address [1] 295925 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 295925 0
Australia
Date submitted for ethics approval [1] 295925 0
25/07/2016
Approval date [1] 295925 0
15/09/2016
Ethics approval number [1] 295925 0

Summary
Brief summary
This study aims to determine the repeatability of an investigational instrument (Liquid Jet Aesthesiometer) and its application in contact lens related comfort. The instrument is used in optometric research to assess corneal sensitivity (i.e. measuring the smallest amount of stimulus for the anterior eye to detect sensation). To achieve this we wish to take measurements using the instrument over several days. Approximately 30 participants (15 contact lens wearers and 15 non-contact lens weares) will take part in each stage of the study. In Stage 1 of the study, we wish to assess the repeatability of the instrument in measuring corneal sensitivity over the course of 5 days. Once this stage is complete and pending data analysis of Stage 1 we may invite you to Stage 2, if you choose to participate, where we aim to assess the correlation between corneal sensitivity measurements and comfort over the course of 3 days. You do not have to participate in both stages of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68874 0
Mr Danny Kho
Address 68874 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 68874 0
Australia
Phone 68874 0
+61 2 9385 7516
Fax 68874 0
Email 68874 0
[email protected]
Contact person for public queries
Name 68875 0
Mr Danny Kho
Address 68875 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 68875 0
Australia
Phone 68875 0
+61 2 9385 7516
Fax 68875 0
Email 68875 0
[email protected]
Contact person for scientific queries
Name 68876 0
Mr Danny Kho
Address 68876 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 68876 0
Australia
Phone 68876 0
+61 2 9385 7516
Fax 68876 0
Email 68876 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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