Intense Pulsed Light Study for Dry Eye Disease

NCT03089580 | Completed Results DMC FDA Device

• 1 other identifier: HUM00119518
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eyes Chronic

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intense Pulsed Light Treatment

EXPERIMENTAL

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

Sham Treatment

PLACEBO COMPARATOR

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

Interventions

Intense Pulsed Light Therapy 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.

Intense Pulsed Light Treatment

Sham Treatment 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.

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Michigan: lead
• Eversight Michigan/Michigan Eye Bank: collaborator

Study Sites (1)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Interventions

Intense Pulsed Light Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Sarah Wood
• Organization: University of Michigan / Kellogg Eye Center

skwood@med.umich.edu

734-615-2479

Study Officials

• Sarah Wood, OD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Ophthalmology and Visual Sciences

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 24, 2017
• Study Start: March 25, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)