Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases (ESPOIR)

June 7, 2011 updated by: Laboratoires Thea

Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Hôpital Gabriel Montpied
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, France, 75012
        • C.H.N.O des XV-XX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: 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, Hôpital Bichat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 21, 2010

First Posted (ESTIMATE)

March 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2420-PIV-CE-01/10
  • N° RCB 2010-A00017-32 (OTHER: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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