Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Phase 1CompletedNCT01190397

Laboratoires Thea20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Eyelid Diseases

Interventions

Warming gogglesDEVICE

warm and moist compressesDEVICE

Eligibility

Sex: ALLMin age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

School of Optometry & Vision Sciences

Cardiff, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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