Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases (ESPOIR Ext)
This study has been completed.
Sponsor:
Laboratoires Thea
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01189474
First received: August 25, 2010
Last updated: October 2, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Eyelid Diseases |
Device: Blephasteam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction. |
Resource links provided by NLM:
Further study details as provided by Laboratoires Thea:
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189474
Locations
| France | |
| CHU d'Amiens | |
| Amiens, France, 80054 | |
| Hopital Pellegrin | |
| Bordeaux, France, 33000 | |
| CHU de Dijon | |
| Dijon, France, 21000 | |
| 76 Allée des Pins Tranquilles | |
| Hossegord, France, 40150 | |
| CHU de Bicêtre | |
| Le Kremlin Bicêtre, France, 94270 | |
| Hopital Claude Huriez | |
| Lille, France, 59000 | |
| Hopital Dupuytren | |
| Limoges, France, 87042 | |
| Hopital Edouard Heriot | |
| Lyon, France, 69000 | |
| 433 bis rue Paradis | |
| Marseille, France, 13000 | |
| Hopital d'instruction des armées LAVERAN | |
| Marseille, France, 13000 | |
| 67 chemin du Fescau | |
| Montferrier sur LEZ, France, 34980 | |
| 60 place Jacques Mirouze | |
| Montpellier, France, 34000 | |
| 3 cours Leopold | |
| Nancy, France, 54000 | |
| Hopital Max Fourestier | |
| Nanterre, France, 92014 | |
| 4 avenue Baquis | |
| Nice, France, 06000 | |
| Centre Hospitalier de Nimes | |
| Nimes, France, 30029 | |
| 22 rue Beaujon | |
| Paris, France, 75000 | |
| Hotel Dieu | |
| Paris, France, 75000 | |
| Fondation Rothschild | |
| Paris, France, 75019 | |
| C.H.N.O des XV-XX | |
| Paris, France, 75012 | |
| 142 Boulevard de Montparnasse | |
| Paris, France, 75014 | |
| 26 rue du Moulin des justices | |
| Puilboreau, France, 17138 | |
| Polyclinique Saint Laurent | |
| Rennes, France, 35000 | |
| CHU de Saint Etienne | |
| Saint Etienne, France, 42000 | |
| CHU Hospices Civils | |
| Strasbourg, France, 67000 | |
| Hôpital de Tarbes | |
| Tarbes, France, 65013 | |
| Clinique du Cours Dillion | |
| Toulouse, France, 31300 | |
| CHU Bretonneau | |
| Tours, France, 37044 | |
| Hopital Brabois Adulte | |
| Vandoeuvre les Nancy, France, 54505 | |
Sponsors and Collaborators
Laboratoires Thea
Investigators
| Principal Investigator: | Jean Paul ADENIS, Professor | Hopital Dupuytren Limoges |
| Principal Investigator: | Isabelle BADELLON, Doctor | Fondation Rothschild (Paris) |
| Principal Investigator: | Vincent BORDERIE, Professor | CHNO des quinze-vingts |
| Principal Investigator: | Tristan BOURCIER, Professor | CHU de Strasbourg |
| Principal Investigator: | Jean Louis BOURGES, Doctor | Hotel Dieu Paris |
| Principal Investigator: | Dominique BREMOND GIGNAC, Professor | CHU d'Amiens |
| Principal Investigator: | Carole BURILLON, Professor | Hopital Edouard Heriot Lyon |
| Principal Investigator: | Philippe CAZEMIND, Doctor | Clinique du cours Dillion |
| Principal Investigator: | Hervé CHENAL, Doctor | |
| Principal Investigator: | Joseph COLIN, Professor | University Hospital, Bordeaux |
| Principal Investigator: | Catherine CREUZOT GARCHER, Professor | CHU de Dijon |
| Principal Investigator: | Stephan FAUQUIER, Doctor | |
| Principal Investigator: | Denis FLORES, Doctor | |
| Principal Investigator: | Philippe GAIN, Professor | CHU de Saint Etienne |
| Principal Investigator: | Olivier Galatoire, Doctor | Fondation Rothschild (Paris) |
| Principal Investigator: | Damien GATINEL, Doctor | Fondation Rothschild (Paris) |
| Principal Investigator: | Jean Luc GEORGES, Professor | CHU de Nancy |
| Principal Investigator: | Thanh HOANG XUAN, Professor | |
| Principal Investigator: | Philippe IMBERT, Doctor | Polyclinique du Parc |
| Principal Investigator: | Marc LABETOULLE, Professor | CH de Bicetre |
| Principal Investigator: | Karim LAOUAR, Doctor | Centre Hospitalier de Nimes |
| Principal Investigator: | Sylvie MAES CASTELLARIN, Doctor | Hopital de Tarbes |
| Principal Investigator: | Sylvie MAINGUY, Doctor | |
| Principal Investigator: | Claire MEURIOT TUIL, Doctor | |
| Principal Investigator: | Solange MILAZZO, Professor | CHU d'Amiens |
| Principal Investigator: | Bruno MORTEMOUSQUE, Doctor | University Hospital, Bordeaux |
| Principal Investigator: | Pierre Jean PISELLA, Professor | CHU de Tours |
| Principal Investigator: | Pierre Yves ROBERT, Professor | University Hospital, Limoges |
| Principal Investigator: | Stephane RONCIN, Doctor | Polyclinique Saint Laurent |
| Principal Investigator: | Jean François ROULAND, Professor | CHU de Lille |
| Principal Investigator: | Pierre LABALETTE, Professor | CHU de Lille |
| Principal Investigator: | Frank ROUX, Doctor | HIA Laveran |
| Principal Investigator: | Claude SPEEG, ¨Professor | CHU de Strasbourg |
| Principal Investigator: | Michel TAZARTES, Doctor | |
| Principal Investigator: | Yves UTEZA, Doctor | |
| Principal Investigator: | Hatem ZEGHIDI, Doctor | |
| Principal Investigator: | Benoit BRIAT, Doctor |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01189474 History of Changes |
| Other Study ID Numbers: | LT2420-PIV-CE-02/10, N° RCB 2010-A00199-30 |
| Study First Received: | August 25, 2010 |
| Last Updated: | October 2, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Laboratoires Thea:
|
Meibomian Gland Dysfunction |
Additional relevant MeSH terms:
|
Eyelid Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013