Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Eyelid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190397
• Other study ID #: LT2420-PI-CE-07/10
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2010
• Last updated: December 3, 2010
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eyelid Diseases

Intervention

Device:
• Warming goggles

• warm and moist compresses

Locations

Country	Name	City	State
United Kingdom	School of Optometry & Vision Sciences	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	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.		No