NCT03089580

Intense Pulsed Light Study for Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eyes Chronic

Interventions

Type	Name	Description
DEVICE	Intense Pulsed Light Therapy	Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants will receive a total of 4 treatments over the course of the study.
PROCEDURE	Sham Treatment	The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.

Timeline

• Start date: 2017-03-25
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2017-03-24
• Last updated: 2019-10-08
• Results posted: 2019-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study