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OpenTrials
Completed

NCT Number: NCT01086943

Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers

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

Prospective, non comparative, open, monocentre study.

The objectives are:

* To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application * To evaluate the ocular surface, NIBUT and IOP before and after device application * To determine the acceptability of healthy volunteers on the practical use of this device

The subjects will attend 2 visits.

Completed

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Key information

Conditions

Eyelid Diseases Eye Diseases

Age range

18 year–80 year

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

LT2420

Device

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers

Important dates

First posted
Mar 15, 2010
Registry last updated
Jan 31, 2012

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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