BroadBand Light for the Treatment of Dry Eye Disease

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Broadband Light treatment; Device: Sham broadband light treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandy Zhang-Nunes, MD; Phone Number: 323-442-6335; Email: sandy.zhang-nunes@med.usc.edu
• Study Contact Backup: Name: Jessica R Chang, MD; Phone Number: 323-442-6785; Email: jessica.chang@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Protocol 1--420 and 560nm wavelengths; 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; While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.; Other Names: Intense Pulsed Light
Active Comparator: Protocol 2--560nm wavelength; 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; While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.; Other Names: Intense Pulsed Light
Sham Comparator: Sham; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Ophthalmic Surgeons & Consultants of Ohio, Inc.
• Investigators: Principal Investigator: Sandy Zhang-Nunes, MD, USC Roski Eye Institute

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dry eye; Meibomian gland dysfunction; Blepharitis; intense pulsed light
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: USCBBLDRYEYE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes