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

Primary Purpose

Eyelid Diseases

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Blephasteam

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01189474

First Posted

August 25, 2010

Last Updated

October 2, 2012

Sponsor

Laboratoires Thea

1. Study Identification

Unique Protocol Identification Number

NCT01189474

Brief Title

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

Acronym

ESPOIR Ext

Official Title

Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratoires Thea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Multicentric study, open label, uncontrolled phase IV in 140 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

104 (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

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: