Clinical trial NCT03788486: Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Treatment Device
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: dry eye
Lead sponsor: Toyos Clinic
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form and HIPPA authorization.
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 -85.
4. 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.
5. History of persistent symptoms despite use of artificial tears.
6. Tear break up time of 7 seconds or less
7. Have normal lid anatomy.
8. Subject is able and willing to comply with the treatment, follow up schedule and requirements.
9. 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.
10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
11. 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.

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Exclusion Criteria:

1. Have a known hypersensitivity or contraindication to the investigational product or components.
2. Pregnancy or lactation
3. 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.
4. Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
5. Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
6. Febrile illness within one week.
7. Treatment with another investigational drug or other intervention within one month.
8. Subjects with a history of herpetic keratitis.
9. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
10. Neuro-paralysis or pre-cancerous lesions in the area to be treated.
11. Radiation to the head or neck within past 12 months.
12. Planned radiation therapy or chemotherapy.
13. Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures.
14. Legally blind in either eye.
15. Facial IPL treatment within 3 months of treatment.
16. Expression of Meibomian glands within 3 months prior to treatment.

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Primary outcomes:
measure: change of non invasive tear break up time over the course of the study
timeFrame: one month
Secondary outcomes:
measure: subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire
timeFrame: one month
measure: change of number of corneal spk stained with fluorescein over the course of the study
timeFrame: one month
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Toyos Clinic
state: Tennessee
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
Study officials:
affiliation: owner
name: Rolando Toyos, MD
role: STUDY_CHAIR
References: