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Intense Pulsed Light Study for Dry Eye Disease

Primary Purpose

Dry Eyes Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intense Pulsed Light Therapy
Sham Treatment
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eyes Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Kellogg Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intense Pulsed Light Treatment

Sham Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2017
Last Updated
September 18, 2019
Sponsor
University of Michigan
Collaborators
Eversight Michigan/Michigan Eye Bank
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1. Study Identification

Unique Protocol Identification Number
NCT03089580
Brief Title
Intense Pulsed Light Study for Dry Eye Disease
Official Title
Intense Pulsed Light Study for Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eversight Michigan/Michigan Eye Bank

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eyes Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intense Pulsed Light Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light Therapy
Intervention Description
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
Procedure
Intervention Name(s)
Sham Treatment
Intervention Description
The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.
Primary Outcome Measure Information:
Title
Tear Breakup Time Average
Description
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.
Time Frame
16.5 weeks
Title
Change in Scores of the Ocular Surface Disease Index Questionnaire
Description
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.
Time Frame
7 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Wood, OD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intense Pulsed Light Study for Dry Eye Disease

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