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

Eyelid Diseases Clinical Trial

— ESPOIR Ext  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189474
• Other study ID #: LT2420-PIV-CE-02/10
• Secondary ID: N° RCB 2010-A001
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2010
• Last updated: October 2, 2012
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

• 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eyelid Diseases

Intervention

Device:
• Blephasteam
Eye lid warming goggles

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	Hopital Pellegrin	Bordeaux
France	CHU de Dijon	Dijon
France	76 Allée des Pins Tranquilles	Hossegord
France	CHU de Bicêtre	Le Kremlin Bicêtre
France	Hopital Claude Huriez	Lille
France	Hopital Dupuytren	Limoges
France	Hopital Edouard Heriot	Lyon
France	433 bis rue Paradis	Marseille
France	Hopital d'instruction des armées LAVERAN	Marseille
France	67 chemin du Fescau	Montferrier sur LEZ
France	60 place Jacques Mirouze	Montpellier
France	3 cours Leopold	Nancy
France	Hopital Max Fourestier	Nanterre
France	4 avenue Baquis	Nice
France	Centre Hospitalier de Nimes	Nimes
France	142 Boulevard de Montparnasse	Paris
France	22 rue Beaujon	Paris
France	C.H.N.O des XV-XX	Paris
France	Fondation Rothschild	Paris
France	Hotel Dieu	Paris
France	26 rue du Moulin des justices	Puilboreau
France	Polyclinique Saint Laurent	Rennes
France	CHU de Saint Etienne	Saint Etienne
France	CHU Hospices Civils	Strasbourg
France	Hôpital de Tarbes	Tarbes
France	Clinique du Cours Dillion	Toulouse
France	CHU Bretonneau	Tours
France	Hopital Brabois Adulte	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France,