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

Thea Pharma

Status and phase: Completed; Phase 4

Conditions: Eyelid Diseases

Treatments: Device: Blephasteam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189474

N° RCB 2010-A00199-30 (Other Identifier)

LT2420-PIV-CE-02/10

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)