NCT01086943

Brief Summary

The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids. Prospective, non comparative, open, monocentre study. The objectives are:

  • To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
  • To evaluate the ocular surface, NIBUT and IOP before and after device application
  • To determine the acceptability of healthy volunteers on the practical use of this device The subjects will attend 2 visits.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 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

March 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

First QC Date

March 12, 2010

Last Update Submit

January 27, 2012

Conditions

Eyelid Diseases

Study Arms (1)

device arm

EXPERIMENTAL
Device: LT2420

Interventions

LT2420DEVICE
device arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

  • Christine Purslow

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 15, 2010

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

GB(1)