Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-02-01
2025-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
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Ophthalmic Surgeons & Consultants of Ohio, Inc.
OTHER
University of Southern California
OTHER
Responsible Party
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Sandy Zhang-Nunes
Director of Oculoplastics, USC Roski Eye Institute
Principal Investigators
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Sandy Zhang-Nunes, MD
Role: PRINCIPAL_INVESTIGATOR
USC Roski Eye Institute
Central Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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USCBBLDRYEYE
Identifier Type: -
Identifier Source: org_study_id