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

Meibomian Gland Dysfunction Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

• NCT number: NCT03788486
• Study type: Interventional
• Source: Toyos Clinic
• Status: Withdrawn
• Phase: N/A
• Start date: February 12, 2019
• Completion date: October 7, 2020