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

NCT ID: NCT01091311

Last Updated: 2011-06-08

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Eyelid Diseases

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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Christophe Baudouin, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Frédéric Chiambaretta, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Serge Doan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hopital Bichat

Locations

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Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

C.H.N.O des XV-XX

Paris, , France

Site Status

Hôpital Bichat - Claude Bernard

Paris, , France

Site Status

Countries

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France

Other Identifiers

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N° RCB 2010-A00017-32

Identifier Type: OTHER

Identifier Source: secondary_id

LT2420-PIV-CE-01/10

Identifier Type: -

Identifier Source: org_study_id

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