NCT01091311

Brief Summary

Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands dysfunction . Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized. This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21. Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

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 19, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

March 19, 2010

Last Update Submit

June 7, 2011

Conditions

Eyelid Diseases

Keywords

Meibomian Gland Dysfunction

Interventions

BlephasteamDEVICE

Eye lid warming goggles

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Signed and dated informed consent. * Male or female up to 4 years old. * Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month. * Without any active pathology requiring a change in ocular treatments within the last month before inclusion. * Best corrected far visual acuity (VA) \> 1/10

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

C.H.N.O des XV-XX

Paris, 75012, France

Location

Hôpital Bichat - Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Eyelid DiseasesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Christophe Baudouin, Professor

    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    PRINCIPAL INVESTIGATOR

  • Frédéric Chiambaretta, Professor

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Serge Doan, Doctor

    Hopital Bichat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 24, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

FR(3)