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

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.

Study Overview

• Status: Withdrawn
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: 2-3 Joule LED blue light device

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Toyos Clinic
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one month
change of number of corneal spk stained with fluorescein over the course of the study	manual counting of number of corneal spk	one month

Collaborators and Investigators

• Sponsor: Toyos Clinic
• Investigators: Study Chair: Rolando Toyos, MD, Owner

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ACTUAL): October 7, 2020
• Study Completion (ANTICIPATED): October 7, 2020

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (ACTUAL): December 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: dry eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction
• Other Study ID Numbers: TCQ2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: non-identifying patient data available upon request
• IPD Sharing Time Frame: one year beginning 6 months after study completion
• IPD Sharing Access Criteria: scientific researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No