Intense Pulsed Light Study for Dry Eye Disease

NCT ID: NCT03089580

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-25
• Study Completion Date: 2018-11-01

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.

Conditions

Dry Eyes Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intense Pulsed Light Therapy

Intervention Type: DEVICE

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.

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.

Group Type: PLACEBO_COMPARATOR

Sham Treatment

Intervention Type: PROCEDURE

The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eversight Michigan/Michigan Eye Bank

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sarah Wood, Ophthalmology

Instructor in Ophthalmology and Visual Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Wood, OD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00119518

Identifier Type: -

Identifier Source: org_study_id