Clinical trial NCT03089580: Intense Pulsed Light Study for Dry Eye Disease
Official title: Intense Pulsed Light Study for Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eyes Chronic
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eversight Michigan/Michigan Eye Bank
First posted: 2017-03-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment of dry eye disease. One eye of the participant will be randomized to receive the IPL treatment.

Detailed description: 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Tear Breakup Time Average
timeFrame: 16.5 weeks
measure: Change in Scores of the Ocular Surface Disease Index Questionnaire
timeFrame: 7 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sarah Wood, OD
role: PRINCIPAL_INVESTIGATOR
References: