Meibomian Gland DysfunctionMGDNCT06278584
iLux Treatment for Meibomian Gland Dysfunction
A study testing iLUX Treatment System in people with Meibomian Gland Dysfunction and Eyes Dry Chronic, run by Clínica de Oftalmología de Cali S.A at 1 site in Colombia.
Trial summary
Summary: Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Eyes Dry Chronic
- What is being tested?
- iLUX Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteColombia
- Study dates
- 15 Oct 2020to 28 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years
- A history of self-reported dry eye symptoms for two months prior to study enrollment,
- Diagnosis of MGD Low delivery type, with mechanism obstructive and non- cicatricial with scores as follows: Ocular Surface Disease Index (OSDI) questionnaire ≥ 13, Non-Invasive Tear break-up time (NIBUT) lower than 10 seconds (The Sirius anterior segment analyzer (CSO, Florence, Italy).
- Meibomian gland scores (MGS) lower than 15.
Who cannot join
- A history of ocular surgery
- Allergic conjunctivitis
- Seborrheic dermatitis
- Rosacea
- Psoriasis
- Punctal plugs or previous punctal cautery
Show all 16Show fewer
- Anterior or demodex blepharitis
- Cicatricial lid margin disease
- Ocular injury or trauma
- Chemical burns
- Limbal stem cell deficiency
- Active ocular infection or non-dry eye inflammation
- Aqueous-deficient dry eye
- Irregular cornea
- Lid abnormalities and systemic disease conditions
- Medications that cause dry eye.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clínica de Oftalmología de Cali S.A
Cali, Valle del Cauca Department, 760036
About this study
Official title: The iLux and Mechanical Meibomian Gland Expression for the Treatment of Moderate and Severe Meibomian Gland Dysfunction.
Summary:
Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).
Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE.
Read the detailed description
Meibomian glands (MG) are responsible for the secretion of lipids (meibum) into the ocular surface and have a protective role for tear film against evaporation1-4; therefore, Meibomian Gland Dysfunction (MGD) is associated with evaporative dry eye (EDE). Hyperkeratinization and hyperviscosity occur in dysfunctions with low MG expressibility, low meibum quality and eyelid margin inflammation. Finally, atrophy and dropout of MGs in some cases could appear MGD is a prevalent dry eye disorder (DED) with an estimated prevalence range between 3.5% and 70%1,10-13, it constitutes the primary underlying pathology within the EDE subtype. On top of this, MGD is chronic and progressive, so it is imperative to identify clinical approaches that can effectively target this underlying condition.
Treatment of MGD often involves artificial lubricants, topical lipid supplements, lid hygiene, warm compression or heat application, supplement omega-3, topical and systemic antibiotics against Demodex mite infestation, and steroids.
Mechanical management involves debridement-scaling of the line of Marx and lowers lid margin21, and other methods for mechanical manual expression in alignment with the concept that optimal treatment of MGD requires the employment of some forms of evacuating MGs contents.
Eyelid thermal pulsation devices combine the application of heat at the appropriate temperature to the palpebral surface with simultaneous compression of the glands to evacuate their contents, and have been shown to improve signs and symptoms over 12 months in cases of severe meibomian obstruction.
More recently, the ILux® MGD Treatment System (Alcon, FortWorth, TX, USA) is an eyelid thermal pulsation system that includes a single-use patient interface device and a portable battery-powered instrument that simultaneously applies localized heat and compression to treat MGD and showed significant improvements in MG function between one and four weeks.
Prior to the introduction of vectored thermal pulsation therapies, the limitations of the practice for mechanical meibomian gland expression (MMGE) were pain caused by forced evacuation of the gland, difficulty with adequate sustained temperature at the eyelid at therapeutic levels ≥ 40°C28, and duration of effect demonstrated in only one month. In the patients five sessions per year of this combined treatment for moderate and severe DGM was performet.
The aim of this study is to compare the safety and efficacy of one-session eyelid treatment with the ILux® DGM treatment device versus five sessions in MMGE consultation in patients with moderate and severe DGM in a follow-up.
- Conditions
- Meibomian Gland Dysfunction, Eyes Dry Chronic
- Being tested
- iLUX Treatment System
- Keywords
- Meibomian Gland Dysfunction, ILux®, ocular surface, dry eye
- 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.
iLUX Treatment SystemDevice
Also called Mechanical Meibomian Gland Expression
Local heat using an electrical warming mask for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| iLUX Treatment System | Active comparator | The eyelid tissue is warmed by light energy produced by LEDs in the Instrument and transmitted through the precise Outer Pad. The Inner Pad and Eye Shield block light transmission directly into the eye during a treatment temperature sensor and measure the inner and outer eyelid temperatures to maintain a meibum melt temperature of 38-42°C. Receives: Device: iLUX Treatment System |
| Mechanical Meibomian Gland Expression | Active comparator | 1. Local heat using an electrical warming mask for 5 minutes.
2. Using a standardized device (Arita Meibomian Gland Compressor, Katena) to apply a standard force to individual glands Receives: Device: iLUX Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds.
NIBUT measured by SIRIUS device in seconds.
Measured: 1 year
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS).
Using a Meibomian Gland Evaluator (MGE 1000) to grade a total score for 15 meibomian glands in the lower eyelid evaluated in 3 areas: nasal (5 glands), medial (5 glands), and temporal (5 glands) expressed \& graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start15 Oct 2020
- Primary completion1 Feb 2021
- Study completion28 Feb 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Oftalmología de Cali S.A
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278584
- Sponsor's protocol ID
- 2020001-00
- Acronym
- MGD
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iLux and Mechanical Meibomian Gland Expression for the Treatment of Moderate and Severe Meibomian Gland Dysfunction.
- ClinicalTrials.gov ID
- NCT06278584
- Acronym / sponsor ID
- MGD / 2020001-00
- Conditions
- Meibomian Gland Dysfunction, Eyes Dry Chronic
- Keywords
- Meibomian Gland Dysfunction, ILux®, ocular surface, dry eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Clínica de Oftalmología de Cali S.AUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Feb 2024 (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.
Summary:
Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).
Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE.
Detailed description
Meibomian glands (MG) are responsible for the secretion of lipids (meibum) into the ocular surface and have a protective role for tear film against evaporation1-4; therefore, Meibomian Gland Dysfunction (MGD) is associated with evaporative dry eye (EDE). Hyperkeratinization and hyperviscosity occur in dysfunctions with low MG expressibility, low meibum quality and eyelid margin inflammation. Finally, atrophy and dropout of MGs in some cases could appear MGD is a prevalent dry eye disorder (DED) with an estimated prevalence range between 3.5% and 70%1,10-13, it constitutes the primary underlying pathology within the EDE subtype. On top of this, MGD is chronic and progressive, so it is imperative to identify clinical approaches that can effectively target this underlying condition.
Treatment of MGD often involves artificial lubricants, topical lipid supplements, lid hygiene, warm compression or heat application, supplement omega-3, topical and systemic antibiotics against Demodex mite infestation, and steroids.
Mechanical management involves debridement-scaling of the line of Marx and lowers lid margin21, and other methods for mechanical manual expression in alignment with the concept that optimal treatment of MGD requires the employment of some forms of evacuating MGs contents.
Eyelid thermal pulsation devices combine the application of heat at the appropriate temperature to the palpebral surface with simultaneous compression of the glands to evacuate their contents, and have been shown to improve signs and symptoms over 12 months in cases of severe meibomian obstruction.
More recently, the ILux® MGD Treatment System (Alcon, FortWorth, TX, USA) is an eyelid thermal pulsation system that includes a single-use patient interface device and a portable battery-powered instrument that simultaneously applies localized heat and compression to treat MGD and showed significant improvements in MG function between one and four weeks.
Prior to the introduction of vectored thermal pulsation therapies, the limitations of the practice for mechanical meibomian gland expression (MMGE) were pain caused by forced evacuation of the gland, difficulty with adequate sustained temperature at the eyelid at therapeutic levels ≥ 40°C28, and duration of effect demonstrated in only one month. In the patients five sessions per year of this combined treatment for moderate and severe DGM was performet.
The aim of this study is to compare the safety and efficacy of one-session eyelid treatment with the ILux® DGM treatment device versus five sessions in MMGE consultation in patients with moderate and severe DGM in a follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLUX Treatment System | Active comparator | Device: iLUX Treatment SystemThe eyelid tissue is warmed by light energy produced by LEDs in the Instrument and transmitted through the precise Outer Pad. The Inner Pad and Eye Shield block light transmission directly into the eye during a treatment temperature sensor and measure the inner and outer eyelid temperatures to maintain a meibum melt temperature of 38-42°C. |
| Mechanical Meibomian Gland Expression | Active comparator | Device: iLUX Treatment System1. Local heat using an electrical warming mask for 5 minutes. 2. Using a standardized device (Arita Meibomian Gland Compressor, Katena) to apply a standard force to individual glands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age at least 18 years
- A history of self-reported dry eye symptoms for two months prior to study enrollment,
- Diagnosis of MGD Low delivery type, with mechanism obstructive and non- cicatricial with scores as follows: Ocular Surface Disease Index (OSDI) questionnaire ≥ 13, Non-Invasive Tear break-up time (NIBUT) lower than 10 seconds (The Sirius anterior segment analyzer (CSO, Florence, Italy).
- Meibomian gland scores (MGS) lower than 15.
Key exclusion criteria (16 listed)
- A history of ocular surgery
- Allergic conjunctivitis
- Seborrheic dermatitis
- Rosacea
- Psoriasis
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 Treatment SystemAlso: Mechanical Meibomian Gland ExpressionLocal heat using an electrical warming mask for 5 minutes. | Device | Mechanical Meibomian Gland Expression, iLUX Treatment System |
Primary outcome
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds.
Time frame: 1 year
NIBUT measured by SIRIUS device in seconds.
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS).
Time frame: 1 year
Using a Meibomian Gland Evaluator (MGE 1000) to grade a total score for 15 meibomian glands in the lower eyelid evaluated in 3 areas: nasal (5 glands), medial (5 glands), and temporal (5 glands) expressed \& graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
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 26 Feb 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLUX Treatment System in people with Meibomian Gland Dysfunction and Eyes Dry Chronic, run by Clínica de Oftalmología de Cali S.A at 1 site in Colombia.
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 4 inclusion and 16 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 26 Feb 2024. 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 Colombia. 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?
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds. (time frame: 1 year). The study lists 2 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 26 Feb 2024.