Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03311204
Registration number
NCT03311204
Ethics application status
Date submitted
11/10/2017
Date registered
17/10/2017
Titles & IDs
Public title
The Effect of Eyelid Margin Debridement on Contact Lens Discomfort
Query!
Scientific title
The Effect and Duration of Efficacy of Eyelid Margin Debridement on Signs and Secretions of Eyelids, Tear Film and Discomfort in Contact Lens Wearers
Query!
Secondary ID [1]
0
0
UNewSouthwales
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Contact Lens Discomfort
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - BlephEx
Other interventions - Lid Hygenix
Experimental: Microblepharon Exfoliation - This treatment is provided using BlephEx tool from Optimed Pty Ltd.
Experimental: Eyelid cleansing using Lid Hygenix - Foam-based hypoallergenic cleanser used as a control treatment in this study.
Treatment: Devices: BlephEx
BlephEx is an instrument that contains a hand piece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.
Other interventions: Lid Hygenix
Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Lid Wiper Epitheliopathy
Query!
Assessment method [1]
0
0
The eyelids will be examined using a slit lamp before and after instillation of sodium fluorescein. This stain helps to disclose changes to the eyelid surface .
Query!
Timepoint [1]
0
0
5 minutes
Query!
Secondary outcome [1]
0
0
Discomfort Rating - CLDEQ-8 Questionnaire
Query!
Assessment method [1]
0
0
Discomfort will be measured using the CLDEQ-8 questionnaire that involves questions about participants' experience of discomfort. This will be employed on all the study visits in the clinic.
Query!
Timepoint [1]
0
0
5 minutes
Query!
Secondary outcome [2]
0
0
End of the Day Discomfort Rating
Query!
Assessment method [2]
0
0
End of the day discomfort will be assessed using a visual analog scale, where questions will be posed to participants about their level of comfort with contact lens wear at a specific time of day. This questionnaire will be a web-based survey, sent in the form of an email on the day before the baseline visit, and day 4, 9, 14, 19 and 24 from baseline visit.
Query!
Timepoint [2]
0
0
30 minutes
Query!
Secondary outcome [3]
0
0
Tear Analysis
Query!
Assessment method [3]
0
0
Change in tear lipids at day 4, 9, 14, 19 and 24 compared to baseline
Query!
Timepoint [3]
0
0
15 minutes
Query!
Secondary outcome [4]
0
0
Meibum Analysis
Query!
Assessment method [4]
0
0
Change in meibum lipids at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [4]
0
0
10 minutes
Query!
Secondary outcome [5]
0
0
Meibography
Query!
Assessment method [5]
0
0
Meibomian gland (glands in eyelids) morphology will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [5]
0
0
5 minutes
Query!
Secondary outcome [6]
0
0
Demodex Infestation
Query!
Assessment method [6]
0
0
Highly magnified images of eyelids will be captured with a microscope to count the number of Demodex on eyelids. these images will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [6]
0
0
15 minutes
Query!
Secondary outcome [7]
0
0
Lid Microbiota
Query!
Assessment method [7]
0
0
Change in colony forming units of cultivable eyelid microbiota will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [7]
0
0
5 minutes
Query!
Secondary outcome [8]
0
0
LipiView Interferometry
Query!
Assessment method [8]
0
0
The change in absolute thickness of the tear film lipid layer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [8]
0
0
10 minutes
Query!
Secondary outcome [9]
0
0
Lid Sensitivity
Query!
Assessment method [9]
0
0
Change in eyelid sensitivity assessed using Cochet Bonnet aesthesiometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [9]
0
0
5 minutes
Query!
Secondary outcome [10]
0
0
Tear Osmolarity
Query!
Assessment method [10]
0
0
Change in tear osmolarity using TearLab osmometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Query!
Timepoint [10]
0
0
5 minutes
Query!
Eligibility
Key inclusion criteria
* Age of 18 years or above
* Understand their rights as a research subject
* Willing and able to sign a statement of informed consent
* Normal ocular status, defined as a minimum of 20/40 visual acuity in each eye; clear corneas without scarring, opacities, or vascularization, as determined by biomicroscopic examination
* Normal external examination
* Normal puncta without punctal plugs
* Ability to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
* 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. These contact lens wearers will be on daily wearing modality, where the subject is supposed to wear it for at least for 6 hours, only during the day and remove the lenses during sleep.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* Any ocular or systemic disease that might influence the tear film and especially subjects with a history of episodes of epilepsy.
* Subjects with eyelid inflammation of more than grade 2 will be excluded from the study as they need therapeutic intervention.
* All conjunctival abnormalities, including pingueculae greater than 1 mm in diameter, location closer than 2 mm to the limbus, or elevated more than 0.2 mm
* All forms of conjunctivitis, including allergic conjunctivitis
* Fluorescein corneal staining of grade 2 or more, after a single installation of non-preserved fluorescein solution followed by examination 1 minute after installation
* Current ocular infection or treatment of such infections with ocular or systemic medications
* Current use of any prescription or non-prescription ocular or systemic medications, including antihistamines
* Use of artificial tear preparations during the period 2 hours before the examination
* Use of any ocular ointment during the 3 days before the examination
* Any history of ocular surgery
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
42
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
University of New South Wales - Kensington
Query!
Recruitment postcode(s) [1]
0
0
2152 - Kensington
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The University of New South Wales
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03311204
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Mark Willcox, D Sc
Query!
Address
0
0
University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
All participants will be given a unique study identification code. Data will be de-identified at the time of collection such that only patient initials and a study identification number will be used to identify the data for each patient. Any data included in reports, publications or presented at meetings will be provided in the form of group responses or study identity numbers, such that the participants cannot be identified. Personal and health information (either identifiable or potentially identifiable) about individuals will not be disclosed to any external parties without the individual's consent unless required by law. The unique study identification code can be broken by the research team if required (re-identifiable).
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03311204