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

Eyelid Diseases Clinical Trial

— ESPOIR  

Official title:

Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091311
• Other study ID #: LT2420-PIV-CE-01/10
• Secondary ID: N° RCB 2010-A000
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2010
• Last updated: June 7, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• 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	Hôpital Gabriel Montpied	Clermont-Ferrand
France	C.H.N.O des XV-XX	Paris
France	Hôpital Bichat - Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France,