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

NCT03788486 | Withdrawn DMC

• 1 other identifier: TCQ2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Meibomian Gland Dysfunction

Keywords

dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire

  one month

• change of number of corneal spk stained with fluorescein over the course of the study

  one month

Study Arms (1)

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.

Device: 2-3 Joule LED blue light device

Interventions

2-3 Joule LED blue light device 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

2-3 Joule light device for MGD/Dry eye

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (2)

Toyos Clinic

Germantown, Tennessee, 38138, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Rolando Toyos, MD

  owner

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: February 12, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: one year beginning 6 months after study completion
• Access Criteria: scientific researcher

Locations

US (2)