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Recruitment Status : Withdrawn (Covid)
First Posted : December 27, 2018
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Meibomian Gland Dysfunction||Device: 2-3 Joule LED blue light device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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)|
|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|
|Actual Primary Completion Date :||October 7, 2020|
|Estimated Study Completion Date :||October 7, 2020|
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
- 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
- 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
- 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
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
|United States, Tennessee|
|Germantown, Tennessee, United States, 38138|
|Nashville, Tennessee, United States, 37215|
|Study Chair:||Rolando Toyos, MD||owner|