Evaluation of Satisfaction Regarding Patient's Management... | NCT01091311

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

NCT01091311

Sponsor

Laboratoires Thea

Status

Completed

Last Update Posted

Jun 8, 2011Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Eyelid Diseases

Interventions

Blephasteam

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N° RCB 2010-A00017-32	Other Identifier	AFSSAPS

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

Mar 21, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
Blephasteam	Device	Eye lid warming goggles

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Baudouin, Professor	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Principal Investigator
Frédéric Chiambaretta, Professor	University Hospital, Clermont-Ferrand	Principal Investigator
Serge Doan, Doctor	Hopital Bichat	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HÃ´pital Gabriel Montpied		Clermont-Ferrand		63003	France
C.H.N.O des XV-XX

Condition Browse Module

MeSH Terms

ID	Term
D005141	Eyelid Diseases
D000080343	Meibomian Gland Dysfunction

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided