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
|Condition or disease||Intervention/treatment||Phase|
|Dry Eyes Chronic||Device: Intense Pulsed Light Therapy Procedure: Sham Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
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
|United States, Michigan|
|University of Michigan Kellogg Eye Center|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Sarah Wood, OD||University of Michigan|