Clinical trial NCT06174064: BroadBand Light for the Treatment of Dry Eye Disease
Official title: Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Keywords: Dry eye
Blepharitis
Meibomian gland dysfunction
intense pulsed light
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Ophthalmic Surgeons & Consultants of Ohio, Inc.
First posted: 2023-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to three arms: protocol 1, 2, and sham
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in dry eye score
timeFrame: 1 month after last BBL treatment (4 month time-point)
Secondary outcomes:
measure: Ocular surface/eyelid microbiome data
timeFrame: 1 month after last BBL treatment
measure: Clinical evaluation of dry eye-- Change in fluorescein staining grade
timeFrame: 1 month after last BBL treatment
measure: Clinical evaluation of dry eye--Change in tear osmolarity
timeFrame: 1 month after last BBL treatment
measure: Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration
timeFrame: 1 month after last BBL treatment
measure: Clinical evaluation of dry eye--Change in tear breakup time
timeFrame: 1 month after last BBL treatment
measure: Clinical evaluation of dry eye--Change in basal tear production
timeFrame: 1 month after last BBL treatment
Other outcomes:
Locations:
Study officials:
affiliation: USC Roski Eye Institute
name: Sandy Zhang-Nunes, MD
role: PRINCIPAL_INVESTIGATOR
References: