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

Thea Pharma

Status and phase: Completed; Phase 1

Conditions: Eyelid Diseases

Treatments: Device: LT2420

Study type: Interventional

Funder types: Industry

Identifiers

NCT01086943

LT2420-PI-CE-07/07

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

25 participants in 1 patient group

device arm

Experimental group

Treatment:

Device: LT2420