Intense Pulsed Light Study for Dry Eye Disease

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.

Study Overview

• Status: Completed
• Conditions: Dry Eyes Chronic
• Intervention / Treatment: Device: Intense Pulsed Light Therapy; Procedure: Sham 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Kellogg Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intense Pulsed Light Treatment; Participants will have one eye randomized to receive the intense pulsed light (IPL) therapy treatment while their other eye will receive the sham treatment. Participants will receive approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level will be based on skin type. IPL will be administered 4 times throughout the study.	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.
PLACEBO_COMPARATOR: Sham Treatment; Participants will have the other eye randomized to receive a sham treatment. The sham treatment will be conducted by placing the intense pulsed light (IPL) device to approximately 15 areas around the eye, lower eyelid, cheek, side of nose and temple without delivery of the light. The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Breakup Time Average	Three tear breakup time measurements will be taken of each eye. The averages of those eyes treated with intense pulsed light treatment will be compared to those eyes that received the sham treatment.	16.5 weeks
Change in Scores of the Ocular Surface Disease Index Questionnaire	Patients completed the Ocular Surface Disease Index Questionnaire at each visit before they received the IPL and sham treatments. The questionnaire is assessed on a scale of 0 to 100 with 0 meaning normal and the higher scores representing greater dry eye disease severity. This questionnaire has been validated to assess ocular symptoms for a patient but cannot be separated by eye. Therefore, the results cannot be given by treatment vs. sham, but for the participant overall.	7 Months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Eversight Michigan/Michigan Eye Bank
• Investigators: Principal Investigator: Sarah Wood, OD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2017
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: HUM00119518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No