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Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Primary Purpose

Eyelid Diseases

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Warming goggles
warm and moist compresses
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Diseases focused on measuring Warming goggles

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Optometry & Vision Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blephasteam Arm

warm and moist compresses arm

Arm Description

Outcomes

Primary Outcome Measures

Temperature measurements
The 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 Outcome Measures

Humidity measurements
The 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.

Full Information

First Posted
August 25, 2010
Last Updated
December 3, 2010
Sponsor
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT01190397
Brief Title
Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy
Official Title
Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratoires Thea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
Warming goggles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blephasteam Arm
Arm Type
Experimental
Arm Title
warm and moist compresses arm
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Warming goggles
Intervention Type
Device
Intervention Name(s)
warm and moist compresses
Primary Outcome Measure Information:
Title
Temperature measurements
Description
The 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 Outcome Measure Information:
Title
Humidity measurements
Description
The 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko PULT, Doctor
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry & Vision Sciences
City
Cardiff
Country
United Kingdom

12. IPD Sharing Statement

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Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

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