IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD

Intense Pulsed Light and Meibomian Gland Expression (MGX) Versus MGX Alone in the Treatment of Dry Eye Disease Secondary 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 expression of the meibomian glands. 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,

Study Overview

• Status: Completed
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Intense Pulsed Light (IPL) therapy; Device: Sham therapy

Detailed Description

Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment, number of meibomian glands yielding liquid secretion in lower eyelid , 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 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 meibomian glands will be manually expressed from both eyelids. 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shaare Zedek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is able to read, understand and sign an Informed Consent (IC) form
2. Subject is 18 years or older
3. Subject has Fitzpatrick skin type I to IV
4. SPEED questionnaire equal or more than 10
5. OSDI questionnaire equal or more than 23
6. In both eyes, at least 5 non-atrophied meibomian glands on the lower eyelid.
7. In both eyes, Tear break up time equal or less than 7 seconds
8. In both eyes, MGA (the total meibomian gland score for 15 glands of the lower eyelid) is smaller or equal to 12

Exclusion Criteria:

1. Contact lens wear within the month prior to screening
2. Unwilling to discontinue use of contact lenses for the duration of the study
3. Ocular surgery or eyelid surgery within 6 months prior to screening
4. Neuro-paralysis in the planned treatment area within 6 months prior to screening
5. Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
6. Current use of punctal plugs
7. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
8. Uncontrolled infections or uncontrolled immunosuppressive diseases
9. Subjects with ocular infections within 6 months prior to screening
10. 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 (e.g., Herpes simplex 1 & 2, Systemic Lupus erythematosus, porphyria)
11. Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort within 3 months prior to screening
12. Over exposure to sun within 4 weeks prior to screening, in the judgment of the investigator
13. Administration of prescription eye drops for dry eye within 7 days prior to screening, excluding artificial tears and glaucoma drops
14. Radiation therapy to the head or neck within 12 months prior to screening, or planned radiation therapy within 8 weeks after completion of all IPL treatments
15. Treatment with chemotherapeutic agent within 8 weeks prior to screening, or planned chemotherapy within 8 weeks after completion of all IPL treatments
16. 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 (such as Extra Strength Tylenol®) for pain management after study treatment, new oral omega 3 fatty acid supplements and topical artificial tears
17. Change in dosage of any systemic medication within 3 months prior to screening
18. Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
19. Legally blind in either or both eyes
20. History of migraines, seizures or epilepsy
21. IPL treatment within 12 months prior to screening
22. Lipiflow treatment, or any other thermal treatment of the eyelids, within 6 months prior to screening
23. Expression of the meibomian glands within 6 months prior to screening
24. Any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study
25. Women below the age of menopause (50 years of age)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intense Pulsed Light (IPL) therapy; Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.	Device: Intense Pulsed Light (IPL) therapy; Intense pulsed light therapy 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 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression 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.
Placebo Comparator: Sham therapy; Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.	Device: Sham therapy; Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of baseline TBUT	Change of Tear break up time in the study eye, from baseline to follow-up	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline MGA	Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes	10 weeks
Change from baseline OSDI	Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline MGYLS	Change of the number of meibomian glands yielding liquid secretion, from baseline to the follow-up	10 weeks
Change from baseline TFO	Change of the tear film osmolarity, from baseline to the follow-up	10 weeks
Change from baseline Meiboscore	Change of the Meiboscore evaluated with meibography, from baseline to the follow-up	10 weeks
Percentage of study eyes with normal TBUT	Percentage of study eyes with TBUT > 10 seconds at the follow-up	10 weeks
Percentage of subjects with normal OSDI	Percentage of subjects with OSDI < 23 at the follow-up	10 weeks
Percentage of subjects with normal MGA	Percentage of eyes with MGA > 12 at the follow-up	10 weeks
Qualitative assessment of eyelid appearance	High resolution photos of the upper and lower eyelids in both eyes	10 weeks

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: David Zadok, MD, Shaarei Zedek Hospital ( Jerusalem)

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): April 18, 2019
• Study Completion (Actual): April 18, 2019

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 27, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Meibomian Gland Dysfunction; Intense Pulsed Light
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: LUM-VBU-IPL-M22-17-02; 0171-17-SZMC (Other Identifier: Shaarei Zedek Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: At this point it is not yet decided if and how to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No