Clinical Trial: Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy

Brief Summary:

The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids

Phase I, prospective, comparative study, investigator masked , monocentric

Objectives are To assess and compare the warming and moisture of Blephasteam® device versus the warming and moisture of warm and moist compresses.

To assess and compare safety on the ocular surface after 10 minutes of Blephasteam® application versus after 10 minutes of warm and moist compresses application


Detailed Summary:
Sponsor: Laboratoires Thea

Current Primary Outcome: Temperature measurements

The temperature in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects


Original Primary Outcome: Same as current

Current Secondary Outcome: Humidity measurements

The humidity in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects.


Original Secondary Outcome: Same as current

Information By: Laboratoires Thea

Dates:
Date Received: August 25, 2010
Date Started: September 2010
Date Completion:
Last Updated: December 3, 2010
Last Verified: December 2010