Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD

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.

Inclusion Criteria:

1. Able to read, understand and sign an Informed Consent (IC) form

2. 18-80 years of age

3. Fitzpatrick skin type 1-4

4. Able and willing to comply with the treatment/follow-up schedule and requirements

5. At least 5 non-atrophied glands on each eye's lower eyelid

6. Current diagnosis of moderate to severe MGD in both eyes, including 2 of the
following 5 criteria:

- 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

7. 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.

Exclusion Criteria:

1. Contact lens wearer within the past 1 month and throughout the study

2. Recent ocular surgery or eyelid surgery within the past 6 months

3. Neuro-paralysis in the planned treatment area within the past 6 months

4. Other uncontrolled eye disorders affecting the ocular surface

5. Current use of punctal plugs

6. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area

7. Uncontrolled infections or uncontrolled immunosuppressive diseases

8. Subjects who have undergone laser in situ keratomileusis (LASIK) surgery within the
past 6 months

9. 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)

10. 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

11. Over exposure to sun within the past 4 weeks, in the judgment of the treating
physician

12. Pregnancy and nursing

13. Administration of prescription eye drops for dry eye within the past 48 hours,
excluding artificial tears

14. Radiation therapy to the head or neck within the past year, or planned radiation
therapy within 8 weeks after completion of all IPL treatments

15. Treatment with chemotherapeutic agent within the past 8 weeks, 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 the
past 3 months, except over-the-counter acetaminophen-based analgesics (such as Extra
Strength Tylenol®) for pain management after study treatment

17. Change in dosage of any systemic medication within the past 3 months

18. Anticipated relocation or extensive travel outside of the local study area preventing
compliance with follow-up within the next 16 weeks

19. Any condition revealed during the eligibility screening process whereby the physician
deems the subject inappropriate for this study

20. Declared legally blind in one eye

21. History of migraines, seizures or epilepsy

22. IPL treatment within the past 12 months

23. Lipiflow treatment, or any equivalent treatment, within the past 12 months

24. Expression of the meibomian glands within the past 12 months