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Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Treatment Device

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ClinicalTrials.gov Identifier: NCT03788486
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Toyos Clinic

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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Device: 2-3 Joule LED blue light device Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
Experimental: 2-3 Joule light device for MGD/Dry eye
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.
Device: 2-3 Joule LED blue light device
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire [ Time Frame: one month ]
    patient completed questionnaire 10 mm in length minimum score 0=no pain and maximal score 100= maximal pain

  2. change of number of corneal spk stained with fluorescein over the course of the study [ Time Frame: one month ]
    manual counting of number of corneal spk



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

    -

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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788486


Contacts
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Contact: MELISSA TOYOS, md 9137064408 mtoyos@toyosclinic.com
Contact: Madison Rupard 6153274015 mrupard@toyosclinic.com

Locations
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United States, Tennessee
Toyos Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact: Haylie Mulliniks, OD    901-683-7255    drmulliniks@gmail.com   
Contact: Shaunna Edmonds    9016837255    sedmonds@toyosclinic.com   
Toyos Clinic Recruiting
Nashville, Tennessee, United States, 37215
Contact: Melissa Toyos    615-327-4015    mtoyos@toyosclinic.com   
Contact: Madison Rupard    6153274015    mrupard@toyosclinic.com   
Sponsors and Collaborators
Toyos Clinic
Investigators
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Study Chair: Rolando Toyos, MD owner

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Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03788486     History of Changes
Other Study ID Numbers: TCQ2019
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: non-identifying patient data available upon request
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: one year beginning 6 months after study completion
Access Criteria: scientific researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toyos Clinic:
dry eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases