NCT03788486

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-12
• Primary completion: 2020-10-07
• Completion: 2020-10-07
• First posted: 2018-12-27
• Last updated: 2020-10-08

Locations

2 sites across 1 country: United States