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

Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091311
Acronym
ESPOIR
Enrollment
30
Registered
2010-03-24
Start date
2010-05-31
Completion date
2010-12-31
Last updated
2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyelid Diseases

Keywords

Meibomian Gland Dysfunction

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.

Interventions

Eye lid warming goggles

Sponsors

Laboratoires Thea
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026