Dry EyePhase 4SHEEPDOGNCT04159935
Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease
A Phase 4 study testing iLux® system in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- iLux® system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2019to 14 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has been using the same CL type (brand, material and dimensions) for > 3 months;
- Wears commercially available soft CLs on average >2 hours per day, 4-7 days per week;
- Is willing to try to wear their habitual CLs on average ≥ 6 hours per day, 4-7 days per week and maintain this for the duration of their involvement in the study;
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- Demonstrates an acceptable lens fit of their habitual contact lenses;
- Does not have contact lens discomfort due to contact lens fit, lens material or known solution compatibility issues, in the opinion of the investigator;
- Has at least one month supply of their habitual contact lens products at the time of the screening visit;
- Has a CLDEQ-8 score ≥ 12;
- Has dry eye symptoms without CL wear (OSDI ≥ 13) and has at least one of the two following signs:
- Non-invasive tear break-up time (NITBUT) of < 10 seconds in at least one eye;
- Fluorescein staining: > 5 spots of corneal staining OR > 9 conjunctival spots OR lid wiper staining (≥ 2mm length, ≥ 25% width) in at least one eye;
- Has a lipid layer thickness of ≤ 100 nm in both eyes;
- A meibomian gland secretion score (MGS) of ≤ 15 for 15 glands of the lower lid in both eyes.
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has used any prescription systemic medications or topical treatments for MGD or dry eye for the past 30 days prior to the screening visit and not willing to stop using these for the study duration (excluding over-the-counter artificial tears, dietary supplements and ocular lubricants but includes warm compresses, eyelid massage, eyelid hygiene, manual meibomian gland expression, punctal plug insertion or punctal occlusion, intense pulsed light treatment of the face or eyelids);
- Has previously received treatment with an eyelid thermal pulsation device;
- Has a history of any of the following ocular (eye or eyelid) conditions or procedures in either eye within the past 90 days prior to the screening visit:
- Ocular trauma
- Chemical burns
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- Ocular Herpes simplex or Herpes zoster infection
- Limbal stem cell deficiency
- Recurrent ocular inflammation (e.g. uveitis, iritis, scleritis, episcleritis, keratitis)
- Has undergone ocular surgery (e.g. intraocular, oculoplastic, corneal or refractive surgery procedure) within the past 12 months prior to the screening visit;
- Has permanent make-up or tattoos on their eyelids;
- Has any other known active* ocular disease and/or infection in either eye including: cicatricial lid margin disease or severe (≥ grade 3) blepharitis; moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis; a hordeolum or stye; ocular surface abnormality that may compromise corneal integrity (e.g. Grade 3 corneal fluorescein staining, recurrent corneal erosion, corneal epithelial defect, map dot fingerprint dystrophy, previously treated chemical burn);
- Has an eyelid abnormality that affects normal lid function (e.g. entropion, ectropion, oedema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis);
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Has any other condition that could compromise treatment or increase the risk of a procedure-related injury;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Has a history of sensitivity to rapidly blinking lights or photosensitive epilepsy;
- Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrolment;
- Is aphakic;
- Is a member of CORE directly involved in the study;
- Has taken part in a clinical research study within the last 30 days. * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE).
- Conditions
- Dry Eye
- Being tested
- iLux® system
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLux® systemDevice
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
| Study group | Role | What they receive |
|---|---|---|
| iLux® treatment | Experimental | The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment. Receives: Device: iLux® system |
| Delayed iLux® treatment | Experimental | Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment. Receives: Device: iLux® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month
The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.
Measured: 1 month
Secondary outcomes (12)
Meibomian Gland Score at Baseline
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Measured: Baseline
Meibomian Gland Score at 1 Month
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Measured: 1 Month
Meibomian Gland Score at 3 Months
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Measured: 3 Months
Comfortable Contact Lens Wear Time at Baseline
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Measured: Baseline
Comfortable Contact Lens Wear Time at 1 Month
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Measured: 1 Month
Comfortable Contact Lens Wear Time at 3 Months
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Measured: 3 Months
Pre-lens Tear Break-up Time at Baseline
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Measured: Baseline
Pre-lens Tear Break-up Time at 1 Month
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Measured: 1 Month
Pre-lens Tear Break-up Time at 3 Months
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Measured: 3 Months
Average Contact Lens Wear Time at Baseline
Participants reported how long they wore their contact lenses on average per day (total wear time).
Measured: Baseline
Average Contact Lens Wear Time at 1 Month
Participants reported how long they wore their contact lenses on average per day (total wear time).
Measured: 1 Month
Average Contact Lens Wear Time at 3 Months
Participants reported how long they wore their contact lenses on average per day (total wear time).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start15 Nov 2019
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Why it stopped: Cancelled due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FCOptom, Principal investigator, Centre for Ocular Research & Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159935
- Sponsor's protocol ID
- 41401
- Acronym
- SHEEPDOG
- Status last verified
- May 2023
- First submitted
- 7 Nov 2019
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04159935
- Acronym / sponsor ID
- SHEEPDOG / 41401
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cancelled due to COVID-19
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 16 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLux® treatment | Experimental | Device: iLux® systemThe treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment. |
| Delayed iLux® treatment | Experimental | Device: iLux® systemDelayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has been using the same CL type (brand, material and dimensions) for > 3 months;
- Wears commercially available soft CLs on average >2 hours per day, 4-7 days per week;
Key exclusion criteria (22 listed)
- Is participating in any concurrent clinical or research study;
- Has used any prescription systemic medications or topical treatments for MGD or dry eye for the past 30 days prior to the screening visit and not willing to stop using these for the study duration (excluding over-the-counter artificial tears, dietary supplements and ocular lubricants but includes warm compresses, eyelid massage, eyelid hygiene, manual meibomian gland expression, punctal plug insertion or punctal occlusion, intense pulsed light treatment of the face or eyelids);
- Has previously received treatment with an eyelid thermal pulsation device;
- Has a history of any of the following ocular (eye or eyelid) conditions or procedures in either eye within the past 90 days prior to the screening visit:
- Has undergone ocular surgery (e.g. intraocular, oculoplastic, corneal or refractive surgery procedure) within the past 12 months prior to the screening visit;
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 |
|---|---|---|
| iLux® systemCommercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids. | Device | Delayed iLux® treatment, iLux® treatment |
Primary outcome
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month
Time frame: 1 month
The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.
12 secondary outcomes
Meibomian Gland Score at Baseline
Time frame: Baseline
Meibomian Gland Score at 1 Month
Time frame: 1 Month
Meibomian Gland Score at 3 Months
Time frame: 3 Months
Comfortable Contact Lens Wear Time at Baseline
Time frame: Baseline
Comfortable Contact Lens Wear Time at 1 Month
Time frame: 1 Month
Comfortable Contact Lens Wear Time at 3 Months
Time frame: 3 Months
Pre-lens Tear Break-up Time at Baseline
Time frame: Baseline
Pre-lens Tear Break-up Time at 1 Month
Time frame: 1 Month
Pre-lens Tear Break-up Time at 3 Months
Time frame: 3 Months
Average Contact Lens Wear Time at Baseline
Time frame: Baseline
Average Contact Lens Wear Time at 1 Month
Time frame: 1 Month
Average Contact Lens Wear Time at 3 Months
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lyndon Jones, PhD, FCOptom principal investigator
Centre for Ocular Research & Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iLux® system in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
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 15 inclusion and 22 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: stopped early, as of the sponsor's last update on 16 May 2023. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month (time frame: 1 month). 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 16 May 2023.