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

This is an interventional treatment trial for Dry Eye focused on measuring Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease Read More

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)