Clinical trial NCT03265652: IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD
Official title: Intense Pulsed Light and Meibomian Gland Expression (MGX) Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Meibomian Gland Dysfunction
Keywords: Intense Pulsed Light
Meibomian Gland Dysfunction
Dry Eye Disease
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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,

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of baseline TBUT
timeFrame: 10 weeks
Secondary outcomes:
measure: Change from baseline MGA
timeFrame: 10 weeks
measure: Change from baseline OSDI
timeFrame: 10 weeks
Other outcomes:
measure: Change from baseline MGYLS
timeFrame: 10 weeks
measure: Change from baseline TFO
timeFrame: 10 weeks
measure: Change from baseline Meiboscore
timeFrame: 10 weeks
measure: Percentage of study eyes with normal TBUT
timeFrame: 10 weeks
measure: Percentage of subjects with normal OSDI
timeFrame: 10 weeks
measure: Percentage of subjects with normal MGA
timeFrame: 10 weeks
measure: Qualitative assessment of eyelid appearance
timeFrame: 10 weeks
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek
Study officials:
affiliation: Shaarei Zedek Hospital ( Jerusalem)
name: David Zadok, MD
role: PRINCIPAL_INVESTIGATOR
References: