Intense Pulsed Light Study for Dry Eye Disease

Dry Eyes Chronic Clinical Trial

Official title:

Intense Pulsed Light Study for Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089580
• Other study ID #: HUM00119518
• Status: Completed
• Phase: N/A
• Start date: March 25, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes Chronic
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eversight Michigan/Michigan Eye Bank

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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