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

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.

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Key information

Conditions

Eyelid Diseases Eye Diseases Meibomian Gland Dysfunction

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU d'Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blephasteam

Device

Eye lid warming goggles

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

Acronym: ESPOIR Ext

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 26, 2010
Registry last updated: Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed