Intense Pulsed Light Study for Dry Eye Disease

Dry eye disease (DED) affects tears and the front surface of the eye. Patients who have DED
can experience symptoms of discomfort, blurry vision, redness, and pain. DED can also cause
tears to become unstable which could result in damage to the front surface of the eye.

There are two types of DED. The one the investigators are studying is called evaporative dry
eye disease. This type of DED occurs because the pores on the eyelids are not functioning
properly. In preliminary studies, a new treatment called Intense Pulsed Light (IPL) has shown
promise to reduce signs and symptoms of evaporative DED. IPL is a non-invasive and non-laser
light treatment that was approved in 1995 by the FDA for dermatology. It is commonly used for
treatment of facial rosacea, acne, and hair, wrinkle and lesion removal. It is not currently
approved for the treatment of dry eye disease. This treatment is thought to provide relief of
evaporative DED symptoms and improve the expression of the pores on the edge of the eyelid.

Inclusion Criteria:

- Willing and able to provide informed consent;

- Diagnosed with evaporative dry eye disease with symptoms for 6 months or more;

- Able and willing to comply with follow-up visits, phone calls and intense pulsed light
treatments;

- Agree to using an effective method of birth control during the course of the study;

- Agree to continue current dry eye treatments during the course of the study;

- Fitzpatrick skin scale[14] of 1 (very fair) to 4 (olive) as determined by an
investigator.

Exclusion Criteria:

- Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by
an investigator;

- Neurotrophic keratitis;

- Ectropion, trauma, or any other lid abnormalities;

- Previous diagnosis of Stevens Johnson syndrome or graft versus host disease;

- Ocular burn, active ocular infection, or active ocular inflammation;

- Currently pregnant or trying to become pregnant in the next 5 months;

- Systemic conditions or currently taking medications which makes light therapy
contraindicated (the use of doxycycline is allowed);

- Tattoos in the treatment area;

- Patients who have had intense pulsed light therapy, Lipiflow or Meibothermoflo within
the past six months;

- Contact lens wear more than one time/week or history of refractive surgery;

- Glaucoma drop use

- Ophthalmic steroid use within the past 30 days;

- Punctal plugs if instilled within 30 days of the start of the study;

- Obvious asymmetry between the two eyes deemed significant by the investigators (such
as punctal plugs or cautery in only one eye, etc);

- History of a trabeculectomy or tube surgery;

- Uncontrolled ocular or systemic disease;

- Ocular or eyelid surgery within the last 6 months;

- Any condition which leads the investigator to believe that the patient cannot comply
with the study requirements and/or the patient may be placed at risk with
participation.