Dry Eye SyndromesNCT02621593
Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD
A study testing M22-IPL in people with Dry Eye Syndromes, run by Lumenis Be Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- M22-IPL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Jan 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, understand and sign an Informed Consent (IC) form
- 18-80 years of age
- Fitzpatrick skin type 1-4
- Able and willing to comply with the treatment/follow-up schedule and requirements
- At least 5 non-atrophied glands on each eye's lower eyelid
- Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria:
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- Tear break-up time (TBUT) ≤ 10 seconds in both eyes;
- Meibomian gland (MG) score (using the Abbreviated MGD grading system for clinical trials) ≥ 11 in both eyes
- Corneal Fluorescein Staining (CFS) score (using the Baylor grading scheme) ≥ 10 in both eyes;
- Tear Osmolarity ≥ 310 milliosmol/L in both eyes, or a difference higher than 8 milliosmol/L between the two eyes
- SPEED ≥ 10
- Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nuvaring and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.
Who cannot join
- Contact lens wearer within the past 1 month and throughout the study
- Recent ocular surgery or eyelid surgery within the past 6 months
- Neuro-paralysis in the planned treatment area within the past 6 months
- Other uncontrolled eye disorders affecting the ocular surface
- Current use of punctal plugs
- Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
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- Uncontrolled infections or uncontrolled immunosuppressive diseases
- Subjects who have undergone laser in situ keratomileusis (LASIK) surgery within the past 6 months
- Diseases in the planned treatment area that could be stimulated by light at 560 nm to 1200 nm (e.g., Herpes simplex 1 and 2, Systemic Lupus erythematosus, porphyria)
- Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, or St. John's Wort
- Over exposure to sun within the past 4 weeks, in the judgment of the treating physician
- Pregnancy and nursing
- Administration of prescription eye drops for dry eye within the past 48 hours, excluding artificial tears
- Radiation therapy to the head or neck within the past year, or planned radiation therapy within 8 weeks after completion of all IPL treatments
- Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy within 8 weeks after completion of all IPL treatments
- New topical treatments within the area to be treated, or oral therapies within the past 3 months, except over-the-counter acetaminophen-based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment
- Change in dosage of any systemic medication within the past 3 months
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up within the next 16 weeks
- Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
- Declared legally blind in one eye
- History of migraines, seizures or epilepsy
- IPL treatment within the past 12 months
- Lipiflow treatment, or any equivalent treatment, within the past 12 months
- Expression of the meibomian glands within the past 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dell Laser Consultants
Austin, Texas, 78746
Gaster Eye Center
Beverly Hills, California, 90211
About this study
Official title: Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.
Read the detailed description
The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments.
The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.
- Conditions
- Dry Eye Syndromes
- Being tested
- M22-IPL
- Keywords
- Meibomian Gland Dysfunction, Dry eye symptoms, Intense Pulsed Light
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M22-IPLDevice
The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of dry eye secondary to MGD | Experimental | Intervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system Receives: Device: M22-IPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-up time in seconds, using the standard Fluorescein staining method
The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film
Measured: from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment
Secondary outcomes (5)
Corneal fluorescein staining score, using the Baylor Scheme
The cornea will be viewed and logically divided to 5 zones: central, superior, inferior, temporal and nasal. In each of the 5 zones, grading will be as follows: 0 dots = 0; 1-5 dots = 1; 16-30 dots = 3; > 30 dots = 4; One point will be added to the score in case of 1 area of confluent staining. Two points will be added to the score in case of two or more areas of confluent staining. The total score is the sum of scores in the 5 zones
Measured: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"
- Thickening of the upper lid margin (0-3, where 0 is normal and 3 is severe). A value of at least 1 (mild) is consistent with DED.
- Vascularity of the upper lid margin (0-3, where 0 is normal and 3 is severe engorgement). A value of at least 1 (mild engorgement) is consistent with DED.
- Number of telangiectasias (0-3, where 0 = none, 1 = single, 2 = two to four and 3 = above four). A value of at least 2 (2-4 telangiectasias) is consistent with DED.
- Of the central 10 glands of the upper eyelid- number of plugged glands: a value of at least 2 is consistent with DED. The total score is computed by summing the scores of the 8 categories above.
Measured: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Subjective symptoms, using the SPEED questionnaire
SPEED is a validated questionnaire for quantifying the subjective symptoms of DED. The questionnaire will be filled by the study investigator (with questions answered by the subject). In 4 symptoms are evaluated: (1) dryness, grittiness or scratchiness; (2) Soreness or Irritation; (3) Burning or watering; and (4) Eye fatigue. Two types of questions are asked about these symptoms: frequency and severity.
In the Frequency questions, subjects evaluate the 4 symptoms above on a 0-3 scale: 0 = Never; 1 = Sometimes; 2 = Often; and 3 = All the time.
In the Severity questions, subjects evaluate the 4 symptoms above on a 0-4 scale: 0 = No problems; 1 = Tolerable (not perfect but not uncomfortable); 2 = Uncomfortable (irritating but does not interfere with my day); 3 = Bothersome (irritating and interferes with my day); and (4) Intolerable (unable to perform my daily tasks). The total score is the sum of the Frequency answers and the Severity answers.
Measured: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample
In this current study, tear osmolarity will be measured using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample (TearLab, San Diego, CA, USA). A small tear sample of 50 nL will be collected from the lower meniscus, using a disposable test chip by passive capillary action, and transferred to the device. Several seconds after the transfer, readings will be given in milliOsmol/L
Measured: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Lipid Layer Thickness in nanometers, using an interferometer
lipid layer thickness will be measured using an interferometer. In interferometry, when white light is projected over the cornea, a color interference pattern is produced due to specular reflection at the lipid-aqueous interface. The reflected colors from the tear film are captured on a high-resolution video. Each recorded pixel is analyzed, and compared with a color progression table. The output is expressed as interference color units (ICUS), which correlate with lipid layer thickness
Measured: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Dell, MD, Principal investigator, Medical Director, Dell LAser Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621593
- Sponsor's protocol ID
- LUM-VBU-M22-15-01
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
- ClinicalTrials.gov ID
- NCT02621593
- Acronym / sponsor ID
- LUM-VBU-M22-15-01
- Conditions
- Dry Eye Syndromes
- Keywords
- Meibomian Gland Dysfunction, Dry eye symptoms, Intense Pulsed Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.
Detailed description
The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments.
The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of dry eye secondary to MGD | Experimental | Device: M22-IPLIntervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to read, understand and sign an Informed Consent (IC) form
- 18-80 years of age
- Fitzpatrick skin type 1-4
- Able and willing to comply with the treatment/follow-up schedule and requirements
- At least 5 non-atrophied glands on each eye's lower eyelid
Key exclusion criteria (24 listed)
- Contact lens wearer within the past 1 month and throughout the study
- Recent ocular surgery or eyelid surgery within the past 6 months
- Neuro-paralysis in the planned treatment area within the past 6 months
- Other uncontrolled eye disorders affecting the ocular surface
- Current use of punctal plugs
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 |
|---|---|---|
| M22-IPLThe IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm. | Device | Treatment of dry eye secondary to MGD |
Primary outcome
Tear Break-up time in seconds, using the standard Fluorescein staining method
Time frame: from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment
The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film
5 secondary outcomes
Corneal fluorescein staining score, using the Baylor Scheme
Time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"
Time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Subjective symptoms, using the SPEED questionnaire
Time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample
Time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Lipid Layer Thickness in nanometers, using an interferometer
Time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
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 2 Feb 2017.
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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.
Steven Dell, MD principal investigator
Medical Director, Dell LAser Consultants
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M22-IPL in people with Dry Eye Syndromes, run by Lumenis Be Ltd. at 2 sites 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 12 inclusion and 24 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Tear Break-up time in seconds, using the standard Fluorescein staining method (time frame: from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment). 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 2 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.