BroadBand Light for the Treatment of Dry Eye Disease
- Conditions
- Meibomian Gland DysfunctionDry Eye Syndromes
- Interventions
- Device: Sham broadband light treatmentDevice: Broadband Light treatment
- Registration Number
- NCT06174064
- Lead Sponsor
- University of Southern California
- Brief Summary
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Sham broadband light treatment 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. Protocol 1--420 and 560nm wavelengths Broadband Light treatment 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. Protocol 2--560nm wavelength Broadband Light treatment 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.
- Primary Outcome Measures
Name Time Method Change in dry eye score 1 month after last BBL treatment (4 month time-point) Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment
- Secondary Outcome Measures
Name Time Method Ocular surface/eyelid microbiome data 1 month after last BBL treatment genomic analysis of ocular surface flora at baseline compared to 1 month post-treatment
Clinical evaluation of dry eye-- Change in fluorescein staining grade 1 month after last BBL treatment Change in Fluorescein staining graded with Oxford scale score from baseline to 1 month post-treatment
Clinical evaluation of dry eye--Change in tear osmolarity 1 month after last BBL treatment Change in tear osmolarity (in milliosm/L) from baseline to 1 month post-treatment
Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration 1 month after last BBL treatment 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
Clinical evaluation of dry eye--Change in tear breakup time 1 month after last BBL treatment Change in tear break up time (in seconds) from baseline to 1 month post-treatment
Clinical evaluation of dry eye--Change in basal tear production 1 month after last BBL treatment Change in basal tear production (in millimeters using standardized filter paper) from baseline to 1 month post-treatment