Meibomian Gland DysfunctionNCT05306561
Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users
A study testing Systane iLux thermal pulsation treatment in people with Meibomian Gland Dysfunction and Dry Eye, run by Periman Eye Institute at 1 site in United States.
Trial summary
To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye
- What is being tested?
- Systane iLux thermal pulsation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible subjects must be 18 years of age or older
- Eligible subjects must be willing and able to provide an English language written Informed Consent Form
- Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
- Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
- Have new contact lens to wear starting the first day after iLux treatment
- Have an OSDI score greater than ≥ 12
Show all 10Show fewer
- Have a CLDEQ8 score ≥ 12
- Have a minimum meibomian gland expression score ≤ 12 (using MGD scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-45.
- Be able and willing to follow instructions and participate in all trial assessments and visits
- Eligible subjects must be fully vaccinated against COVID-19
Who cannot join
- Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
- Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
- Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
- Be a woman who is pregnant, nursing, or planning a pregnancy
- Had ocular surgery within the last 90 days
- Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1
Show all 9Show fewer
- Had Intense Pulsed Light (IPL) treatment within last 30 days
- Have active ocular infection or inflammation
- Be a current wearer of extended wear contact lenses
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Periman Eye Institute
Seattle, Washington, 98119
Sathi Maiti, OD, 206-347-0821, sathi.maiti@gmail.com
Christeen Denui, 2063470821, christeen@perimaneyeinstitute.com
About this study
Official title: A Single Arm, Single Center Phase 4 Study to Evaluate Impact of a Single Systane iLux MGD Treatment Device Thermal Pulsation Treatment on Contact Lens Wearing Time and Tolerability, Meibomian Gland Secretion Scores, and Subjective Dry Eye Symptoms in Soft Contact Lens Wearing Subjects With Meibomian Gland Dysfunction
To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.
Read the detailed description
A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Being tested
- Systane iLux thermal pulsation treatment
- Keywords
- dry eye disease, meibomian gland dysfunction, ilux, thermal pulsation, contact lens
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane iLux thermal pulsation treatmentProcedure or surgery
Systane iLux thermal pulsation uses light emitting diode (LED) technology to emit light that is absorbed by pigments (melanin and hemoglobin) in the eyelid. The pigments convert the light energy to heat, which is then transferred to the surrounding tissues, including the meibomian glands. The device heats the eyelid to 40-42°C and maintains it above 40°C during the heating period, which can be 40 seconds or more. This helps melt the meibum. After the heating phase, the meibomian glands are expressed with the built in expression system.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single arm trial Receives: Procedure: Systane iLux thermal pulsation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.
Measured: 1 month
Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
CLDEQ8 (Contact Lens Dry Eye Questionnaire) is a subjective contact lens discomfort and dryness questionnaire. A lower CLDEQ8 score represents less frequent and/or less severe symptoms
Measured: 1 month
Percentage of subjects with improvement in MGSS from baseline to 1 month
MGSS (Meibomian gland secretion score). 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
Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
Total comfortable soft contact lens wearing time per week will be asked via questionnaire.
Measured: 1 month
Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.
Total soft contact lens wearing time per week will be asked via questionnaire.
Measured: 1 month
Secondary outcomes (2)
Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month
Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute and Oxford grading scales.
Measured: 1 month
Mean change in TBUT from baseline to 1 month
The investigator instilled sodium fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start26 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Periman Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306561
- Sponsor's protocol ID
- PEI-IIT-70111343
- Status last verified
- Nov 2023
- First submitted
- 23 Mar 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Center Phase 4 Study to Evaluate Impact of a Single Systane iLux MGD Treatment Device Thermal Pulsation Treatment on Contact Lens Wearing Time and Tolerability, Meibomian Gland Secretion Scores, and Subjective Dry Eye Symptoms in Soft Contact Lens Wearing Subjects With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05306561
- Acronym / sponsor ID
- PEI-IIT-70111343
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Keywords
- dry eye disease, meibomian gland dysfunction, ilux, thermal pulsation, contact lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Periman Eye InstituteUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Apr 2022 (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.
To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.
Detailed description
A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Systane iLux thermal pulsation treatmentSingle arm trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligible subjects must be 18 years of age or older
- Eligible subjects must be willing and able to provide an English language written Informed Consent Form
- Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
- Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
- Have new contact lens to wear starting the first day after iLux treatment
Key exclusion criteria (9 listed)
- Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
- Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
- Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
- Be a woman who is pregnant, nursing, or planning a pregnancy
- Had ocular surgery within the last 90 days
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 |
|---|---|---|
| Systane iLux thermal pulsation treatmentSystane iLux thermal pulsation uses light emitting diode (LED) technology to emit light that is absorbed by pigments (melanin and hemoglobin) in the eyelid. The pigments convert the light energy to heat, which is then transferred to the surrounding tissues, including the meibomian glands. The device heats the eyelid to 40-42°C and maintains it above 40°C during the heating period, which can be 40 seconds or more. This helps melt the meibum. After the heating phase, the meibomian glands are expressed with the built in expression system. | Procedure or surgery | Arm 1 |
Primary outcome
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
Time frame: 1 month
OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.
Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
Time frame: 1 month
CLDEQ8 (Contact Lens Dry Eye Questionnaire) is a subjective contact lens discomfort and dryness questionnaire. A lower CLDEQ8 score represents less frequent and/or less severe symptoms
Percentage of subjects with improvement in MGSS from baseline to 1 month
Time frame: 1 month
MGSS (Meibomian gland secretion score). 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.
Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
Time frame: 1 month
Total comfortable soft contact lens wearing time per week will be asked via questionnaire.
Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.
Time frame: 1 month
Total soft contact lens wearing time per week will be asked via questionnaire.
2 secondary outcomes
Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month
Time frame: 1 month
Mean change in TBUT from baseline to 1 month
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane iLux thermal pulsation treatment in people with Meibomian Gland Dysfunction and Dry Eye, run by Periman Eye Institute at 1 site in United States.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sathi Maiti, OD (2063470821, sathi.maiti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month (time frame: 1 month). The study lists 5 primary outcomes in all. 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 18 Nov 2023.