BroadBand Light for the Treatment of Dry Eye Disease

University of Southern California60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Syndromes Meibomian Gland Dysfunction

Interventions

Broadband Light treatmentDEVICE

While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.

Sham broadband light treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in dry eye score

Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment

Time frame: 1 month after last BBL treatment (4 month time-point)