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

January 27, 2012 updated by: Laboratoires Thea

Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom
        • School of Optometry & Vision Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: device arm
Device: LT2420

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Christine Purslow, Cardiff University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2420-PI-CE-07/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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