BroadBand Light for the Treatment of Dry Eye Disease

NCT06174064 | Unknown FDA Device

• 1 other identifier: USCBBLDRYEYE
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Keywords

Dry eye; Blepharitis; Meibomian gland dysfunction; intense pulsed light

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Ocular surface/eyelid microbiome data

  1 month after last BBL treatment

• Clinical evaluation of dry eye-- Change in fluorescein staining grade

  1 month after last BBL treatment

• Clinical evaluation of dry eye--Change in tear osmolarity

  1 month after last BBL treatment

• Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration

  1 month after last BBL treatment

• Clinical evaluation of dry eye--Change in tear breakup time

  1 month after last BBL treatment

Study Arms (3)

Protocol 1--420 and 560nm wavelengths

ACTIVE COMPARATOR

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

Protocol 2--560nm wavelength

ACTIVE COMPARATOR

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

Sham

SHAM COMPARATOR

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

Interventions

Broadband Light treatment DEVICE

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

Also known as: Intense Pulsed Light

Protocol 1--420 and 560nm wavelengths; Protocol 2--560nm wavelength

Sham broadband light treatment DEVICE

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.

Sham

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Ophthalmic Surgeons & Consultants of Ohio, Inc.: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction; Blepharitis

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Sandy Zhang-Nunes, MD

  USC Roski Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Zhang-Nunes, MD

CONTACT

323-442-6335; sandy.zhang-nunes@med.usc.edu

Jessica R Chang, MD

CONTACT

323-442-6785; jessica.chang@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomized to protocol 1, 2, or sham but will not be aware of their assignment; investigators grading dry eye at baseline and after treatment will not be aware of which protocol the patients underwent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oculoplastics, USC Roski Eye Institute

Model Details: Participants will be randomized to three arms: protocol 1, 2, and sham

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: December 18, 2023
• Study Start: February 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 30, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share