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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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
Toyos Clinic
Germantown, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
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
Time frame: one month
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
Time frame: one month
change of number of corneal spk stained with fluorescein over the course of the study
manual counting of number of corneal spk
Time frame: one month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.