NCT01190397

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 6, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

August 25, 2010

Last Update Submit

December 3, 2010

Conditions

Eyelid Diseases

Keywords

Warming goggles

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Humidity measurements

Study Arms (2)

Blephasteam Arm

EXPERIMENTAL
Device: Warming goggles

warm and moist compresses arm

ACTIVE COMPARATOR
Device: warm and moist compresses

Interventions

Warming gogglesDEVICE
Blephasteam Arm
warm and moist compressesDEVICE
warm and moist compresses arm

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Optometry & Vision Sciences

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Heiko PULT, Doctor

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 6, 2010

Record last verified: 2010-12

Locations

GB(1)