Clinical Trial: Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study for Evaluation of LipiFlow Screening Methods
Brief Summary: The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.
Detailed Summary:
Sponsor: TearScience, Inc.
Current Primary Outcome: Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) [ Time Frame: Baseline and 4 Weeks ]
Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.
Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: TearScience, Inc.
Dates:
Date Received: September 14, 2010
Date Started: September 2010
Date Completion:
Last Updated: November 1, 2011
Last Verified: November 2011
