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

NCT ID: NCT01189474

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Eyelid Diseases

Keywords

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Blephasteam

Eye lid warming goggles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Best corrected far visual acuity (VA) \> 1/10
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jean Paul ADENIS, Professor

Role: PRINCIPAL_INVESTIGATOR

Hopital Dupuytren Limoges

Isabelle BADELLON, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fondation Rothschild Paris

Vincent BORDERIE, Professor

Role: PRINCIPAL_INVESTIGATOR

CHNO des quinze-vingts

Tristan BOURCIER, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Strasbourg

Jean Louis BOURGES, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Paris

Dominique BREMOND GIGNAC, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire, Amiens

Carole BURILLON, Professor

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Heriot Lyon

Philippe CAZEMIND, Doctor

Role: PRINCIPAL_INVESTIGATOR

Clinique du cours Dillion

Hervé CHENAL, Doctor

Role: PRINCIPAL_INVESTIGATOR

Joseph COLIN, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Catherine CREUZOT GARCHER, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Stephan FAUQUIER, Doctor

Role: PRINCIPAL_INVESTIGATOR

Denis FLORES, Doctor

Role: PRINCIPAL_INVESTIGATOR

Philippe GAIN, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Olivier Galatoire, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fondation Rothschild Paris

Damien GATINEL, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fondation Rothschild Paris

Jean Luc GEORGES, Professor

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Thanh HOANG XUAN, Professor

Role: PRINCIPAL_INVESTIGATOR

Philippe IMBERT, Doctor

Role: PRINCIPAL_INVESTIGATOR

Polyclinique du Parc

Marc LABETOULLE, Professor

Role: PRINCIPAL_INVESTIGATOR

CH de Bicetre

Karim LAOUAR, Doctor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Nimes

Sylvie MAES CASTELLARIN, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hopital de Tarbes

Sylvie MAINGUY, Doctor

Role: PRINCIPAL_INVESTIGATOR

Claire MEURIOT TUIL, Doctor

Role: PRINCIPAL_INVESTIGATOR

Solange MILAZZO, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire, Amiens

Bruno MORTEMOUSQUE, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Pierre Jean PISELLA, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Tours

Pierre Yves ROBERT, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Stephane RONCIN, Doctor

Role: PRINCIPAL_INVESTIGATOR

Polyclinique Saint Laurent

Jean François ROULAND, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Pierre LABALETTE, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Frank ROUX, Doctor

Role: PRINCIPAL_INVESTIGATOR

HIA Laveran

Claude SPEEG, ¨Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Strasbourg

Michel TAZARTES, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yves UTEZA, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hatem ZEGHIDI, Doctor

Role: PRINCIPAL_INVESTIGATOR

Benoit BRIAT, Doctor

Role: PRINCIPAL_INVESTIGATOR

Locations

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CHU d'Amiens

Amiens, , France

Site Status

Hopital Pellegrin

Bordeaux, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

76 Allée des Pins Tranquilles

Hossegord, , France

Site Status

CHU de Bicêtre

Le Kremlin Bicêtre, , France

Site Status

Hopital Claude Huriez

Lille, , France

Site Status

Hopital Dupuytren

Limoges, , France

Site Status

Hopital Edouard Heriot

Lyon, , France

Site Status

433 bis rue Paradis

Marseille, , France

Site Status

Hopital d'instruction des armées LAVERAN

Marseille, , France

Site Status

67 chemin du Fescau

Montferrier-sur-Lez, , France

Site Status

60 place Jacques Mirouze

Montpellier, , France

Site Status

3 cours Leopold

Nancy, , France

Site Status

Hopital Max Fourestier

Nanterre, , France

Site Status

4 avenue Baquis

Nice, , France

Site Status

Centre Hospitalier de Nimes

Nîmes, , France

Site Status

22 rue Beaujon

Paris, , France

Site Status

Hotel Dieu

Paris, , France

Site Status

C.H.N.O des XV-XX

Paris, , France

Site Status

142 Boulevard de Montparnasse

Paris, , France

Site Status

Fondation Rothschild

Paris, , France

Site Status

26 rue du Moulin des justices

Puilboreau, , France

Site Status

Polyclinique Saint Laurent

Rennes, , France

Site Status

CHU de Saint Etienne

Saint-Etienne, , France

Site Status

CHU Hospices Civils

Strasbourg, , France

Site Status

Hôpital de Tarbes

Tarbes, , France

Site Status

Clinique du Cours Dillion

Toulouse, , France

Site Status

CHU Bretonneau

Tours, , France

Site Status

Hopital Brabois Adulte

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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N° RCB 2010-A00199-30

Identifier Type: OTHER

Identifier Source: secondary_id

LT2420-PIV-CE-02/10

Identifier Type: -

Identifier Source: org_study_id