Contact Lens DiscomfortNCT03311204
The Effect of Eyelid Margin Debridement on Contact Lens Discomfort
A study testing BlephEx and Lid Hygenix in people with Contact Lens Discomfort, run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Discomfort
- What is being tested?
- BlephEx and Lid Hygenix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2017to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of New South Wales
Kensington, New South Wales, 2152
About this study
Official 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
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.
Read the detailed description
Contact lens discomfort (CLD) is a substantial problem experienced frequently by contact lens wearers and it is the primary factor associated with permanent discontinuation of lens wear. Studies report that between 43% and 72% of contact lens wearer's dropout due to discomfort. Reducing the number of contact lens (CL) patient dropouts has been a continuing challenge for eye care professionals. With more than 125 million contact lens wearers around the world, patient discontinuations can have a considerable economic impact on an eye care practice.
Definition: Contact lens discomfort is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear.
Inferences from our earlier study (HC15119) showed that eyelid margin debridement significantly improves eyelid signs, tear film properties and comfort in contact lens wearers. But the previous study did not consider the duration of efficacy as the subjects were only followed up once after 7-10days from treatment. Observing subjects more frequently will help us understand the duration of efficacy of debridement therapy. Also, the previous study did not examine the biochemical changes to tear film lipids that are produced by the eyelids.
It is hypothesized that debridement of eyelid margins improves lipid secretions that then help to form a stable lipid layer over ocular surface, thereby improving the tear evaporation dynamics and comfort in contact lens wearers.
Aim: The aim of the study is to observe the duration of efficacy of debridement of the eyelid margins in improving secretions from eyelid glands and whether the debridement helps to form a stable tear film over ocular surface, thereby improving comfort in contact lens wearers.
Objectives: To determine the effect of BlephEx - debridement therapy (an in-office eyelid treatment) on eyelid signs and secretions, tear film and contact lens discomfort.
To observe differences in discomfort in contact lens wearers To determine the duration of efficacy of BlephEx debridement therapy in contact lens wearers, by following up after 12-15 days and 22-25days from the baseline (Treatment) visit.
Methods: The study employs cross-sectional study design, to observe the effect of treatment at three instances, one baseline (treatment) visit and two follow-up visits. At the baseline visit, informed consent will be obtained from the subjects and assessment of the study variables will be performed. Participants will undergo treatment on the same day with BlephEx. At baseline, the measurements are performed prior to treatment to record preliminary scores and then treatment is performed. Participants are asked to return to the clinic for follow-up visits during which no treatment will be performed, but variables are assessed to determine the difference from baseline measurements. The 2nd visit will be after 12 -16 days after the baseline visit. The last follow-up will be 22-26 days after the baseline visit. All study variables will be assessed during all three visits to the clinic.
Treatment Procedure: BlephEx is an instrument that contains a handpiece 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.
Lid Hygenix is a commercially available formulated hypoallergenic foam cleanser will be used to moisten the BlephEx debridement tips.
Both the products are commercially available. The procedure is safe, painless and regularly performed by optometrists.
'Participant information sheet and informed consent' and 'web-based survey for the end of the day discomfort rating' will be sent out in the form of an email. Participants who are interested in participation will respond to the survey and results will be used only after the subject signs the informed consent in the presence of the investigator, during the baseline visit. This survey response will be used as baseline data for the end of the day discomfort.
- Conditions
- Contact Lens Discomfort
- Being tested
- BlephEx, Lid Hygenix
- Keywords
- Eyelid margin, Tear Film, Debridement, Contact Lens, Ocular Discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephExDevice
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.
Lid HygenixOther
Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.
| Study group | Role | What they receive |
|---|---|---|
| Microblepharon Exfoliation | Experimental | This treatment is provided using BlephEx tool from Optimed Pty Ltd. Receives: Device: BlephEx |
| Eyelid cleansing using Lid Hygenix | Experimental | Foam-based hypoallergenic cleanser used as a control treatment in this study. Receives: Other: Lid Hygenix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 5 minutes
Secondary outcomes (10)
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.
Measured: 5 minutes
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.
Measured: 30 minutes
Tear Analysis
Change in tear lipids at day 4, 9, 14, 19 and 24 compared to baseline
Measured: 15 minutes
Meibum Analysis
Change in meibum lipids at day 4, 9, 14, 19 and 24 compared to baseline.
Measured: 10 minutes
Meibography
Meibomian gland (glands in eyelids) morphology will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Measured: 5 minutes
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.
Measured: 15 minutes
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.
Measured: 5 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
Tear Osmolarity
Change in tear osmolarity using TearLab osmometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, cross-over, open-label interventional study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaya Sowjanya Siddireddy, The University of New South Wales
- Investigators
- Mark Willcox, D Sc, Study chair, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311204
- Sponsor's protocol ID
- UNewSouthwales
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2017
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03311204
- Acronym / sponsor ID
- UNewSouthwales
- Conditions
- Contact Lens Discomfort
- Keywords
- Eyelid margin, Tear Film, Debridement, Contact Lens, Ocular Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Contact lens discomfort (CLD) is a substantial problem experienced frequently by contact lens wearers and it is the primary factor associated with permanent discontinuation of lens wear. Studies report that between 43% and 72% of contact lens wearer's dropout due to discomfort. Reducing the number of contact lens (CL) patient dropouts has been a continuing challenge for eye care professionals. With more than 125 million contact lens wearers around the world, patient discontinuations can have a considerable economic impact on an eye care practice.
Definition: Contact lens discomfort is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear.
Inferences from our earlier study (HC15119) showed that eyelid margin debridement significantly improves eyelid signs, tear film properties and comfort in contact lens wearers. But the previous study did not consider the duration of efficacy as the subjects were only followed up once after 7-10days from treatment. Observing subjects more frequently will help us understand the duration of efficacy of debridement therapy. Also, the previous study did not examine the biochemical changes to tear film lipids that are produced by the eyelids.
It is hypothesized that debridement of eyelid margins improves lipid secretions that then help to form a stable lipid layer over ocular surface, thereby improving the tear evaporation dynamics and comfort in contact lens wearers.
Aim: The aim of the study is to observe the duration of efficacy of debridement of the eyelid margins in improving secretions from eyelid glands and whether the debridement helps to form a stable tear film over ocular surface, thereby improving comfort in contact lens wearers.
Objectives: To determine the effect of BlephEx - debridement therapy (an in-office eyelid treatment) on eyelid signs and secretions, tear film and contact lens discomfort.
To observe differences in discomfort in contact lens wearers To determine the duration of efficacy of BlephEx debridement therapy in contact lens wearers, by following up after 12-15 days and 22-25days from the baseline (Treatment) visit.
Methods: The study employs cross-sectional study design, to observe the effect of treatment at three instances, one baseline (treatment) visit and two follow-up visits. At the baseline visit, informed consent will be obtained from the subjects and assessment of the study variables will be performed. Participants will undergo treatment on the same day with BlephEx. At baseline, the measurements are performed prior to treatment to record preliminary scores and then treatment is performed. Participants are asked to return to the clinic for follow-up visits during which no treatment will be performed, but variables are assessed to determine the difference from baseline measurements. The 2nd visit will be after 12 -16 days after the baseline visit. The last follow-up will be 22-26 days after the baseline visit. All study variables will be assessed during all three visits to the clinic.
Treatment Procedure: BlephEx is an instrument that contains a handpiece 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.
Lid Hygenix is a commercially available formulated hypoallergenic foam cleanser will be used to moisten the BlephEx debridement tips.
Both the products are commercially available. The procedure is safe, painless and regularly performed by optometrists.
'Participant information sheet and informed consent' and 'web-based survey for the end of the day discomfort rating' will be sent out in the form of an email. Participants who are interested in participation will respond to the survey and results will be used only after the subject signs the informed consent in the presence of the investigator, during the baseline visit. This survey response will be used as baseline data for the end of the day discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized, cross-over, open-label interventional study
| Arm | Type | Receives |
|---|---|---|
| Microblepharon Exfoliation | Experimental | Device: BlephExThis treatment is provided using BlephEx tool from Optimed Pty Ltd. |
| Eyelid cleansing using Lid Hygenix | Experimental | Other: Lid HygenixFoam-based hypoallergenic cleanser used as a control treatment in this study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlephExBlephEx 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. | Device | Microblepharon Exfoliation |
| Lid HygenixFoam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study. | Other | Eyelid cleansing using Lid Hygenix |
Primary outcome
Lid Wiper Epitheliopathy
Time frame: 5 minutes
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 .
10 secondary outcomes
Discomfort Rating - CLDEQ-8 Questionnaire
Time frame: 5 minutes
End of the Day Discomfort Rating
Time frame: 30 minutes
Tear Analysis
Time frame: 15 minutes
Meibum Analysis
Time frame: 10 minutes
Meibography
Time frame: 5 minutes
Demodex Infestation
Time frame: 15 minutes
Lid Microbiota
Time frame: 5 minutes
LipiView Interferometry
Time frame: 10 minutes
Lid Sensitivity
Time frame: 5 minutes
Tear Osmolarity
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Willcox, D Sc study chair
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlephEx and Lid Hygenix in people with Contact Lens Discomfort, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lid Wiper Epitheliopathy (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.