BroadBand Light for the Treatment of Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174064
• Other study ID #: USCBBLDRYEYE
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: Sandy Zhang-Nunes, MD
• Phone: 323-442-6335
• Email: sandy.zhang-nunes[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 30, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Ophthalmic Surgeons & Consultants of Ohio, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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