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

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Thea Pharma

Status and phase

Completed
Phase 4

Conditions

Eyelid Diseases

Treatments

Device: Blephasteam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01091311
LT2420-PIV-CE-01/10
N° RCB 2010-A00017-32 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

30 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)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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