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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03311204




Registration number
NCT03311204
Ethics application status
Date submitted
11/10/2017
Date registered
17/10/2017
Date last updated
20/03/2020

Titles & IDs
Public title
The Effect of Eyelid Margin Debridement on Contact Lens Discomfort
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
Secondary ID [1] 0 0
UNewSouthwales
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Discomfort 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lid Wiper Epitheliopathy - 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 .
Timepoint [1] 0 0
5 minutes
Secondary outcome [1] 0 0
Discomfort Rating - CLDEQ-8 Questionnaire - 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.
Timepoint [1] 0 0
5 minutes
Secondary outcome [2] 0 0
End of the Day Discomfort Rating - 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.
Timepoint [2] 0 0
30 minutes
Secondary outcome [3] 0 0
Tear Analysis - Change in tear lipids at day 4, 9, 14, 19 and 24 compared to baseline
Timepoint [3] 0 0
15 minutes
Secondary outcome [4] 0 0
Meibum Analysis - Change in meibum lipids at day 4, 9, 14, 19 and 24 compared to baseline.
Timepoint [4] 0 0
10 minutes
Secondary outcome [5] 0 0
Meibography - Meibomian gland (glands in eyelids) morphology will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Timepoint [5] 0 0
5 minutes
Secondary outcome [6] 0 0
Demodex Infestation - 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.
Timepoint [6] 0 0
15 minutes
Secondary outcome [7] 0 0
Lid Microbiota - Change in colony forming units of cultivable eyelid microbiota will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Timepoint [7] 0 0
5 minutes
Secondary outcome [8] 0 0
LipiView Interferometry - 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.
Timepoint [8] 0 0
10 minutes
Secondary outcome [9] 0 0
Lid Sensitivity - Change in eyelid sensitivity assessed using Cochet Bonnet aesthesiometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Timepoint [9] 0 0
5 minutes
Secondary outcome [10] 0 0
Tear Osmolarity - Change in tear osmolarity using TearLab osmometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Timepoint [10] 0 0
5 minutes

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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 hospital [1] 0 0
University of New South Wales - Kensington
Recruitment postcode(s) [1] 0 0
2152 - Kensington

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03311204
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Willcox, D Sc
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications