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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01086943
Other study ID # LT2420-PI-CE-07/07
Secondary ID
Status Completed
Phase Phase 1
First received March 12, 2010
Last updated January 27, 2012

Study information

Verified date January 2012
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
LT2420


Locations

Country Name City State
United Kingdom School of Optometry & Vision Sciences Cardiff

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

United Kingdom, 

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