Dry Eye SyndromeNCT03396913
Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
A study testing IPL and MGX in people with Dry Eye Syndrome, run by Lumenis Be Ltd. at 2 sites in United States.
Trial summary
The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- IPL and MGX
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2018to 15 Aug 2019
- Phase
- Interventional
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand and sign an Informed Consent (IC) form
- 22-85 years of age
- Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
- In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds
- In the study eye, Meibomian Gland Score (MGS) ≤ 12
- In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
- Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23
Who cannot join
- Fitzpatrick skin type V or VI
- Contact lens wear within the month prior to screening
- Unwilling to discontinue use of contact lenses for the duration of the study
- Ocular surgery or eyelid surgery, within 6 months prior to screening
- Neuro-paralysis in the planned treatment area, within 6 months prior to screening
- Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
Show all 33Show fewer
- Current use of punctal plugs
- Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
- Uncontrolled infections or uncontrolled immunosuppressive diseases
- Subjects with ocular infections, within 6 months prior to screening
- Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 \& 2, Systemic Lupus erythematosus, and porphyria
- Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
- Over exposure to sun, within 4 weeks prior to screening
- Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
- Radiation therapy to the head or neck, within 12 months prior to screening
- Planned radiation therapy, within 8 weeks after the last treatment session
- Treatment with chemotherapeutic agent, within 8 weeks prior to screening
- Planned chemotherapy, within 8 weeks after the last treatment session
- New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears
- Change in dosage of any systemic medication, within 3 months prior to screening
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
- Legally blind in either eye
- History of migraines, seizures or epilepsy
- Facial IPL treatment, within 12 months prior to screening
- Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening
- Expression of the meibomian glands, within 6 months prior to screening
- In either eye, moderate to severe (Grade 3-4) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
- In either eye, severe (Grade 4) inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis
- Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
- Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
- Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome
- Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit.
- Any condition revealed whereby the investigator deems the subject inappropriate for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dell Laser Consultants
Austin, Texas, 78746
Toyos Clinic
Nashville, Tennessee, 37215
About this study
Official title: Effectiveness of Intense Pulsed Light for Improving Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction
The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.
Read the detailed description
Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with intense pulsed light (IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
- Conditions
- Dry Eye Syndrome
- Being tested
- IPL, Sham IPL, MGX
- Keywords
- Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease
- 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.
IPLDevice
Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Sham IPLDevice
Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
MGXProcedure or surgery
Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps
| Study group | Role | What they receive |
|---|---|---|
| IPL followed by Meibomian Gland Expression (MGX) | Experimental | Subjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Receives: Device: IPL; Procedure: MGX |
| Sham IPL followed by MGX | Sham comparator | Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Receives: Device: Sham IPL; Procedure: MGX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Baseline Tear Breakup Time (TBUT)
Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.
Measured: 10 weeks
Secondary outcomes (2)
Change From Baseline Ocular Surface Disease Index (OSDI)
Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up. OSDI was collected per patient (one number per patient). The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye.
Measured: 10 weeks
Change From Baseline Eye Dryness Score (EDS)
Change of self-assessed symptoms on a visual analog scale (VAS) , from baseline to follow-up, in both eyes. Values were collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. VAS scores are not validated for dry eye. Hence, it is not known how to correlate VAS values to severity levels of dry eye. However, one can make estimations from the literature of VAS in other conditions. For example, in patients with chronic musculoskeletal pain, in a VAS scale of 0 to 10 scores below 3.4 corresponded to mild pain, scores between 3.5 and 7.4 corresponded to moderate pain, and scores above 7.5 corresponded to severe pain. Using such results from other conditions, it is *estimated* that values between 0 and 34 correspond to mild symptoms, scores between 35 and 74 correspond to moderate symptoms, and scores above 75 correspond to severe symptoms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start10 Jan 2018
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
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 Eye SyndromeStudies 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
- Model description
- Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven J Dell, MD, Principal investigator, Dell Laser ConsultantsRolando Toyos, MD, Principal investigator, Toyos ClinicNeel Desai, MD, Principal investigator, The Eye Institute of West Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396913
- Sponsor's protocol ID
- LUM-VBU-M22-IPL-17-01
- Status last verified
- Sep 2020
- First submitted
- 28 Dec 2017
- Last updated
- 9 Dec 2020
- 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 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intense Pulsed Light for Improving Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03396913
- Acronym / sponsor ID
- LUM-VBU-M22-IPL-17-01
- Conditions
- Dry Eye Syndrome
- Keywords
- Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.
Detailed description
Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with intense pulsed light (IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
| Arm | Type | Receives |
|---|---|---|
| IPL followed by Meibomian Gland Expression (MGX) | Experimental | Device: IPL, Procedure: MGXSubjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes. |
| Sham IPL followed by MGX | Sham comparator | Device: Sham IPL, Procedure: MGXSubjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able to read, understand and sign an Informed Consent (IC) form
- 22-85 years of age
- Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
- In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds
- In the study eye, Meibomian Gland Score (MGS) ≤ 12
Key exclusion criteria (33 listed)
- Fitzpatrick skin type V or VI
- Contact lens wear within the month prior to screening
- Unwilling to discontinue use of contact lenses for the duration of the study
- Ocular surgery or eyelid surgery, within 6 months prior to screening
- Neuro-paralysis in the planned treatment area, within 6 months prior to screening
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 |
|---|---|---|
| IPLIntense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. | Device | IPL followed by Meibomian Gland Expression (MGX) |
| Sham IPLSham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. | Device | Sham IPL followed by MGX |
| MGXMeibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps | Procedure or surgery | IPL followed by Meibomian Gland Expression (MGX), Sham IPL followed by MGX |
Primary outcome
Change of Baseline Tear Breakup Time (TBUT)
Time frame: 10 weeks
Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.
2 secondary outcomes
Change From Baseline Ocular Surface Disease Index (OSDI)
Time frame: 10 weeks
Change From Baseline Eye Dryness Score (EDS)
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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 J Dell, MD principal investigator
Dell Laser Consultants
Rolando Toyos, MD principal investigator
Toyos Clinic
Neel Desai, MD principal investigator
The Eye Institute of West Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL and MGX in people with Dry Eye Syndrome, 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 7 inclusion and 33 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 9 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2020). 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?
Change of Baseline Tear Breakup Time (TBUT) (time frame: 10 weeks). 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 9 Dec 2020.