Meibomian Gland DysfunctionNCT03788486
Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Treatment Device
A study testing 2-3 Joule LED blue light device in people with Meibomian Gland Dysfunction, run by Toyos Clinic at 2 sites in United States.
Trial summary
This study will test the efficacy and safety of application of LED light to meibomian glands in upper and lower eyelids in eyes of patients suffering with meibomian gland disease. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- 2-3 Joule LED blue light device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2019to 7 Oct 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 -85.
- Diagnosed with mild to severe dry eye in one or both eyes with evidence of Meibomian gland dysfunction: cloudy or thick secretions, lack of secretions or presence of telengiectasias on the lower lid margin.
- History of persistent symptoms despite use of artificial tears.
- Tear break up time of 7 seconds or less
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- Have normal lid anatomy.
- Subject is able and willing to comply with the treatment, follow up schedule and requirements.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the study.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni- or bilateral oophorectomy, or bilateral oophorectomy.
- -
Who cannot join
- Have a known hypersensitivity or contraindication to the investigational product or components.
- Pregnancy or lactation
- Subjects can be on the following medications if they have been on a stable dose for 12 weeks: topical cyclosporine, topical liftigrast and/or topical loteprednol etabonate. Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressive agents including oral corticosteroids, non-steroidals, antihistamines, or mast cell stabilizers, punctal plugs, contact lens wear and glaucoma medications.
- Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
- Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
- Febrile illness within one week.
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- Treatment with another investigational drug or other intervention within one month.
- Subjects with a history of herpetic keratitis.
- Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
- Neuro-paralysis or pre-cancerous lesions in the area to be treated.
- Radiation to the head or neck within past 12 months.
- Planned radiation therapy or chemotherapy.
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures.
- Legally blind in either eye.
- Facial IPL treatment within 3 months of treatment.
- Expression of Meibomian glands within 3 months prior to treatment.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Toyos Clinic
Germantown, Tennessee, 38138
Toyos Clinic
Nashville, Tennessee, 37215
About this study
Official title: A Phase 4 Study to Assess the Clinical Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Light Treatment Device
This study will test the efficacy and safety of application of LED light to meibomian glands in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.
Read the detailed description
This study will test the efficacy and safety of application of LED light to meibomian glands in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.
The primary objective of the study is to investigate the safety and efficacy of blue LED light with meibomian gland expression of the upper and lower eyelids in dry eye disease by change from baseline in subjective questionnaire and by measurement of non-invasive tear break up time.
Primary Endpoint: Improvement of tear break up time over the length of the study
Secondary endpoint: subjective patient comfort over the length of the study using a validated dry eye comfort questionnaire administered at each study visit, VAS, 0= no pain and 100 = maximal discomfort, Improvement in the number of corneal SPK that stain with fluorescein.
20 study subjects 18-85 will be enrolled with male or female in the Nashville and Memphis, TN areas who are generally healthy but have signs and symptoms of dry eye disease with Meibomian gland dysfunction.
phase 4
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- 2-3 Joule LED blue light device
- Keywords
- dry eye
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-3 Joule LED blue light deviceDevice
application of blue light LED light device for 2 minutes in the central lower lids, temporal lower lids and upper temporal lids twice weekly under observation for one month
| Study group | Role | What they receive |
|---|---|---|
| 2-3 Joule light device for MGD/Dry eye | Experimental | patients who qualify for the study will receive interventional in office treatments with the light treatment device in the upper and lower lids for defined periods of time twice weekly for a total of one month. Non-invasive tear break up, subjective questionnaires and corneal fluorescein staining will be measured through the course of the study. Receives: Device: 2-3 Joule LED blue light device |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of non invasive tear break up time over the course of the study
3 measurements of non invasive tear break up time by investigator with average recorded
Measured: one month
Secondary outcomes (2)
subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire
patient completed questionnaire 10 mm in length minimum score 0=no pain and maximal score 100= maximal pain
Measured: one month
change of number of corneal spk stained with fluorescein over the course of the study
manual counting of number of corneal spk
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start12 Feb 2019
- Primary completion7 Oct 2020
- Study completion7 Oct 2020 (estimated)
Why it stopped: Covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single site prospective study with no control group to assess the safety and clinical efficacy of a low power LED light device on the signs and symptoms of dry eye disease.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolando Toyos, MD, Study chair, owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788486
- Sponsor's protocol ID
- TCQ2019
- Status last verified
- Oct 2020
- First submitted
- 25 Dec 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: non-identifying patient data available upon request
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study to Assess the Clinical Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Light Treatment Device
- ClinicalTrials.gov ID
- NCT03788486
- Acronym / sponsor ID
- TCQ2019
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- dry eye
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (estimated)
- First posted
- 27 Dec 2018 (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.
This study will test the efficacy and safety of application of LED light to meibomian glands in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.
Detailed description
This study will test the efficacy and safety of application of LED light to meibomian glands in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.
The primary objective of the study is to investigate the safety and efficacy of blue LED light with meibomian gland expression of the upper and lower eyelids in dry eye disease by change from baseline in subjective questionnaire and by measurement of non-invasive tear break up time.
Primary Endpoint: Improvement of tear break up time over the length of the study
Secondary endpoint: subjective patient comfort over the length of the study using a validated dry eye comfort questionnaire administered at each study visit, VAS, 0= no pain and 100 = maximal discomfort, Improvement in the number of corneal SPK that stain with fluorescein.
20 study subjects 18-85 will be enrolled with male or female in the Nashville and Memphis, TN areas who are generally healthy but have signs and symptoms of dry eye disease with Meibomian gland dysfunction.
phase 4
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single site prospective study with no control group to assess the safety and clinical efficacy of a low power LED light device on the signs and symptoms of dry eye disease.
| Arm | Type | Receives |
|---|---|---|
| 2-3 Joule light device for MGD/Dry eye | Experimental | Device: 2-3 Joule LED blue light devicepatients who qualify for the study will receive interventional in office treatments with the light treatment device in the upper and lower lids for defined periods of time twice weekly for a total of one month. Non-invasive tear break up, subjective questionnaires and corneal fluorescein staining will be measured through the course of the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 -85.
- Diagnosed with mild to severe dry eye in one or both eyes with evidence of Meibomian gland dysfunction: cloudy or thick secretions, lack of secretions or presence of telengiectasias on the lower lid margin.
- History of persistent symptoms despite use of artificial tears.
Key exclusion criteria (17 listed)
- Have a known hypersensitivity or contraindication to the investigational product or components.
- Pregnancy or lactation
- Subjects can be on the following medications if they have been on a stable dose for 12 weeks: topical cyclosporine, topical liftigrast and/or topical loteprednol etabonate. Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressive agents including oral corticosteroids, non-steroidals, antihistamines, or mast cell stabilizers, punctal plugs, contact lens wear and glaucoma medications.
- Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
- Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
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 |
|---|---|---|
| 2-3 Joule LED blue light deviceapplication of blue light LED light device for 2 minutes in the central lower lids, temporal lower lids and upper temporal lids twice weekly under observation for one month | Device | 2-3 Joule light device for MGD/Dry eye |
Primary outcome
change of non invasive tear break up time over the course of the study
Time frame: one month
3 measurements of non invasive tear break up time by investigator with average recorded
2 secondary outcomes
subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire
Time frame: one month
change of number of corneal spk stained with fluorescein over the course of the study
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. non-identifying patient data available upon request
Related trials for Meibomian Gland Dysfunction
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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
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.
Rolando Toyos, MD study chair
owner
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-3 Joule LED blue light device in people with Meibomian Gland Dysfunction, run by Toyos Clinic at 2 sites in United States.
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 12 inclusion and 17 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of non invasive tear break up time over the course of the study (time frame: one month). 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 8 Oct 2020.