Dry Eye SyndromesNCT06174064
BroadBand Light for the Treatment of Dry Eye Disease
A study testing Broadband Light treatment in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by University of Southern California.
Trial summary
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Broadband Light treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
Read the detailed 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.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Broadband Light treatment, Sham broadband light treatment
- Keywords
- Dry eye, Blepharitis, Meibomian gland dysfunction, intense pulsed light
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broadband Light treatmentDevice
Also called Intense Pulsed Light
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 treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Sham broadband light treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dry eye score
Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment
Measured: 1 month after last BBL treatment (4 month time-point)
Secondary outcomes (6)
Ocular surface/eyelid microbiome data
genomic analysis of ocular surface flora at baseline compared to 1 month post-treatment
Measured: 1 month after last BBL treatment
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month after last BBL treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to three arms: protocol 1, 2, and sham
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Ophthalmic Surgeons & Consultants of Ohio, Inc.
- Responsible party
- Principal investigator, Sandy Zhang-Nunes, University of Southern California
- Investigators
- Sandy Zhang-Nunes, MD, Principal investigator, USC Roski Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174064
- Sponsor's protocol ID
- USCBBLDRYEYE
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT06174064
- Acronym / sponsor ID
- USCBBLDRYEYE
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- Dry eye, Blepharitis, Meibomian gland dysfunction, intense pulsed light
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Ophthalmic Surgeons & Consultants of Ohio, Inc.
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be randomized to three arms: protocol 1, 2, and sham
| Arm | Type | Receives |
|---|---|---|
| Protocol 1--420 and 560nm wavelengths | Active comparator | Device: Broadband Light treatmentBroadband 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. |
| Protocol 2--560nm wavelength | Active comparator | Device: Broadband Light treatmentBroadband 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. |
| Sham | Sham comparator | Device: Sham broadband light treatmentSham 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broadband Light treatmentAlso: Intense Pulsed LightWhile shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine. | Device | Protocol 1--420 and 560nm wavelengths, Protocol 2--560nm wavelength |
| Sham broadband light treatmentThe 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. | Device | Sham |
Primary outcome
Change in dry eye score
Time frame: 1 month after last BBL treatment (4 month time-point)
Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment
6 secondary outcomes
Ocular surface/eyelid microbiome data
Time frame: 1 month after last BBL treatment
Clinical evaluation of dry eye-- Change in fluorescein staining grade
Time frame: 1 month after last BBL treatment
Clinical evaluation of dry eye--Change in tear osmolarity
Time frame: 1 month after last BBL treatment
Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration
Time frame: 1 month after last BBL treatment
Clinical evaluation of dry eye--Change in tear breakup time
Time frame: 1 month after last BBL treatment
Clinical evaluation of dry eye--Change in basal tear production
Time frame: 1 month after last BBL treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandy Zhang-Nunes, MD principal investigator
USC Roski Eye Institute
Questions about this trial
What is this clinical trial studying?
A study testing Broadband Light treatment in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Zhang-Nunes, MD (323-442-6335, sandy.zhang-nunes@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dry eye score (time frame: 1 month after last BBL treatment (4 month time-point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.