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

Phase 1

Completed

• Conditions: Eyelid Diseases
• Interventions: Device: LT2420

• Registration Number: NCT01086943
• Lead Sponsor: Laboratoires Thea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
device arm	LT2420	-

Trial Locations

Locations (1)

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