BroadBand Light for the Treatment of Dry Eye Disease

University of Southern California

Status: Not yet enrolling

Conditions: Meibomian Gland Dysfunction; Dry Eye Syndromes

Treatments: Device: Sham broadband light treatment; Device: Broadband Light treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06174064

USCBBLDRYEYE

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Protocol 1--420 and 560nm wavelengths

Active Comparator group

Description:

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.

Treatment:

Device: Broadband Light treatment

Protocol 2--560nm wavelength

Active Comparator group

Description:

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.

Treatment:

Device: Broadband Light treatment

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham broadband light treatment