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Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01190397
Enrollment
20
Registered
2010-08-27
Start date
2010-09-30
Completion date
2010-11-30
Last updated
2010-12-06

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

Conditions

Eyelid Diseases

Keywords

Warming goggles

Brief summary

The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids Phase I, prospective, comparative study, investigator masked , monocentric Objectives are To assess and compare the warming and moisture of Blephasteam® device versus the warming and moisture of warm and moist compresses. To assess and compare safety on the ocular surface after 10 minutes of Blephasteam® application versus after 10 minutes of warm and moist compresses application

Interventions

DEVICEWarming goggles
DEVICEwarm and moist compresses

Sponsors

Laboratoires Thea
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Temperature measurementsThe temperature in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects

Secondary

MeasureTime frameDescription
Humidity measurementsThe humidity in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects.

Countries

United Kingdom

Outcome results

None listed

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