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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01086943

Enrollment

Registered

2010-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyelid Diseases

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.

Interventions

DEVICELT2420

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026