Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Phase 1

Completed

• Conditions: Eyelid Diseases
• Interventions: Device: Warming goggles; Device: warm and moist compresses

• Registration Number: NCT01190397
• Lead Sponsor: Laboratoires Thea

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Study Start: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female aged from 18 to 80 years old.
• Healthy volunteers.
• For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
• Normal ocular examination in both eyes.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blephasteam Arm	Warming goggles	-
warm and moist compresses arm	warm and moist compresses	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

School of Optometry & Vision Sciences; 🇬🇧 Cardiff, United Kingdom