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Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

NCT ID: NCT01190397

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Eyelid Diseases

Keywords

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Warming goggles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Blephasteam Arm

Group Type EXPERIMENTAL

Warming goggles

Intervention Type DEVICE

warm and moist compresses arm

Group Type ACTIVE_COMPARATOR

warm and moist compresses

Intervention Type DEVICE

Interventions

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Warming goggles

Intervention Type DEVICE

warm and moist compresses

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Principal Investigators

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Heiko PULT, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Locations

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School of Optometry & Vision Sciences

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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LT2420-PI-CE-07/10

Identifier Type: -

Identifier Source: org_study_id