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| Name | Class |
|---|---|
| Ophthalmic Surgeons & Consultants of Ohio, Inc. | OTHER |
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The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Sandy Zhang-Nunes, MD | USC Roski Eye Institute | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2023 | Dec 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2018 | Feb 1, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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Participants will be randomized to three arms: protocol 1, 2, and sham
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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.
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| 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. |
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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 |