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

Primary Purpose

Meibomian Gland Dysfunction

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2-3 Joule LED blue light device

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring dry eye

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
-

Exclusion Criteria:

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.
Expression of Meibomian glands within 3 months prior to treatment.
-

Sites / Locations

Toyos Clinic
Toyos Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2-3 Joule light device for MGD/Dry eye

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

manual counting of number of corneal spk

Full Information

NCT ID

NCT03788486

First Posted

December 25, 2018

Last Updated

October 7, 2020

Sponsor

Toyos Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03788486

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Covid

Study Start Date

February 12, 2019 (Actual)

Primary Completion Date

October 7, 2020 (Actual)

Study Completion Date

October 7, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toyos Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction

Keywords

dry eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2-3 Joule light device for MGD/Dry eye

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

2-3 Joule LED blue light device

Intervention Description

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 Measure Information:

Title

change of non invasive tear break up time over the course of the study

Description

3 measurements of non invasive tear break up time by investigator with average recorded

Time Frame

one month

Secondary Outcome Measure Information:

Title

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

Description

patient completed questionnaire 10 mm in length minimum score 0=no pain and maximal score 100= maximal pain

Time Frame

one month

Title

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

Description

manual counting of number of corneal spk

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. - Exclusion Criteria: 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. Expression of Meibomian glands within 3 months prior to treatment. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolando Toyos, MD

Organizational Affiliation

owner

Official's Role

Study Chair

Facility Information:

Facility Name

Toyos Clinic

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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