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Intense Pulsed Light Study for Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089580
Recruitment Status : Completed
First Posted : March 24, 2017
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Eversight Michigan/Michigan Eye Bank
Information provided by (Responsible Party):
Sarah Wood, Ophthalmology, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Dry Eyes Chronic Device: Intense Pulsed Light Therapy Procedure: Sham Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intense Pulsed Light Study for Dry Eye Disease
Actual Study Start Date : March 25, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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.




Primary Outcome Measures :
  1. Tear Breakup Time Average [ Time Frame: 16.5 weeks ]
    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.

  2. Change in Scores of the Ocular Surface Disease Index Questionnaire [ Time Frame: 7 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089580


Locations
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United States, Michigan
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Eversight Michigan/Michigan Eye Bank
Investigators
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Principal Investigator: Sarah Wood, OD University of Michigan
  Study Documents (Full-Text)

Documents provided by Sarah Wood, Ophthalmology, University of Michigan:
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Responsible Party: Sarah Wood, Ophthalmology, Instructor in Ophthalmology and Visual Sciences, University of Michigan
ClinicalTrials.gov Identifier: NCT03089580    
Other Study ID Numbers: HUM00119518
First Posted: March 24, 2017    Key Record Dates
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases