BroadBand Light for the Treatment of Dry Eye Disease

Study Overview
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Brief Summary
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The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.

Detailed Description
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Broadband light (BBL) is a widely used treatment for improvement of inflammatory dermatologic conditions such as acne and rosacea, and may have similar therapeutic benefits on the treatment of dry eye disease by targeting inflammation of the eyelids. The investigators propose a prospective study to determine the safety and efficacy of BBL treatment on patients with dry eye disease and meibomian gland dysfunction. Each participant will have three treatments of BBL at monthly intervals to the cheek and periorbital area with subsequent follow up. Measured endpoints will include signs and symptoms of dry eye control including full ophthalmic exam, dry eye diagnostic testing, photographs, and standardized questionnaires.

Official Title
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Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction

Conditions
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Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Broadband Light treatment
* Device: Sham broadband light treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick Skin Type I-V Must be diagnosed with Dry eye disease (DED) and meibomian gland dysfunction (MGD) Persistent dry eye signs and or symptoms after at least one prior DED treatment modality Exclusion Criteria: Prior Intense pulsed light treatment for DED within the past six months Prior Meibomian gland treatment with a device for DED within the past three months History of trauma-induced ocular surface disease (thermal burns, chemical burns) Subject is pregnant History of seizures Having significant unprotected sun exposure within the treatment area Use of Accutane within the last six months Use of doxycycline in the last 1 month Allergy to proparacaine or lidocaine Having active herpes simplex virus infection within the treatment area Laser eye surgery (LASIK) within the past twelve months History of abnormal response to sunlight Having an active medical condition that may affect normal healing Having active infections or compromised immune system History of basal cell carcinoma in the treatment area within the past twelve months History of keloid scar formation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to three arms: protocol 1, 2, and sham
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protocol 1--420 and 560nm wavelengths<br>Broadband light treatment Patients will be treated with BBL with 420nm wavelength filter followed by 560nm wavelength filter to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last BBL treatment. | Device: Broadband Light treatment<br>* While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.<br>* Other names: Intense Pulsed Light;|
| Active Comparator: Protocol 2--560nm wavelength<br>Broadband Light treatment Patients will be treated with BBL with 560nm wavelength filter to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last BBL treatment. | Device: Broadband Light treatment<br>* While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.<br>* Other names: Intense Pulsed Light;|
| Sham Comparator: Sham<br>Sham Broadband Light Treatment Patients will undergo the same preparation and procedure as for BBL treatment but the light source will be occluded. Patients will be treated with sham to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last sham treatment. | Device: Sham broadband light treatment<br>* The light will be occluded on the usual BBL device so that no treatment is delivered but the preparation and procedure will otherwise be the same.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dry eye score | Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment | 1 month after last BBL treatment (4 month time-point) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface/eyelid microbiome data | genomic analysis of ocular surface flora at baseline compared to 1 month post-treatment | 1 month after last BBL treatment | 
| Clinical evaluation of dry eye-- Change in fluorescein staining grade | Change in Fluorescein staining graded with Oxford scale score from baseline to 1 month post-treatment | 1 month after last BBL treatment | 
| Clinical evaluation of dry eye--Change in tear osmolarity | Change in tear osmolarity (in milliosm/L) from baseline to 1 month post-treatment | 1 month after last BBL treatment | 
| Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration | Change in MMP-9 testing (test is positive for MMP-9 level above 40ng/mL, and negative if below that threshold) from baseline to 1 month post-treatment | 1 month after last BBL treatment | 
| Clinical evaluation of dry eye--Change in tear breakup time | Change in tear break up time (in seconds) from baseline to 1 month post-treatment | 1 month after last BBL treatment | 
| Clinical evaluation of dry eye--Change in basal tear production | Change in basal tear production (in millimeters using standardized filter paper) from baseline to 1 month post-treatment | 1 month after last BBL treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Blepharitis, Meibomian gland dysfunction, intense pulsed light