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

Primary Purpose

Eyelid Diseases

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Blephasteam
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Diseases focused on measuring Meibomian Gland Dysfunction

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Hôpital Gabriel Montpied
  • C.H.N.O des XV-XX
  • Hôpital Bichat - Claude Bernard

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 19, 2010
Last Updated
June 7, 2011
Sponsor
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT01091311
Brief Title
Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases
Acronym
ESPOIR
Official Title
Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratoires Thea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Blephasteam
Intervention Description
Eye lid warming goggles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Baudouin, Professor
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric Chiambaretta, Professor
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serge Doan, Doctor
Organizational Affiliation
Hopital Bichat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
C.H.N.O des XV-XX
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases

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