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OpenTrials
Completed

NCT Number: NCT01190397

Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

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

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Key information

Conditions

Eyelid Diseases Eye Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

School of Optometry & Vision Sciences

Cardiff, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warming goggles

Device

warm and moist compresses

Device

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2010
Registry last updated
Dec 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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