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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01091311
First received: March 19, 2010
Last updated: June 7, 2011
Last verified: June 2011

March 19, 2010
June 7, 2011
May 2010
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01091311 on ClinicalTrials.gov Archive Site
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Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases
Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

Multicentric study, open label, uncontrolled phase IV in 30 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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Eyelid Diseases
Device: Blephasteam
Eye lid warming goggles
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2010
December 2010   (final data collection date for primary outcome measure)
  • 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
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01091311
LT2420-PIV-CE-01/10, N° RCB 2010-A00017-32
No
Not Provided
Laboratoires Thea
Not Provided
Principal Investigator: Christophe Baudouin, Professor Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Principal Investigator: Frédéric Chiambaretta, Professor Centre Hospitalier Universitaire de Clermont-Ferrand
Principal Investigator: Serge Doan, Doctor Hopital Bichat
Laboratoires Thea
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP