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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


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, 

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