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Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01190397
First received: August 25, 2010
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Eyelid Diseases
Device: Warming goggles
Device: warm and moist compresses
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Temperature measurements [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blephasteam Arm Device: Warming goggles
Active Comparator: warm and moist compresses arm Device: warm and moist compresses

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190397

Locations
United Kingdom
School of Optometry & Vision Sciences
Cardiff, United Kingdom
Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Heiko PULT, Doctor Cardiff University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01190397     History of Changes
Other Study ID Numbers: LT2420-PI-CE-07/10
Study First Received: August 25, 2010
Last Updated: December 3, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Laboratoires Thea:
Warming goggles

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on November 20, 2014