Eyelid DiseasesPhase 4ESPOIRNCT01091311
Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases
A Phase 4 study testing Blephasteam in people with Eyelid Diseases, run by Laboratoires Thea at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Eyelid Diseases
- What is being tested?
- Blephasteam
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- May 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
C.H.N.O des XV-XX
Paris, 75012
Hôpital Bichat - Claude Bernard
Paris, 75018
About this study
Official title: Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.
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.
- Conditions
- Eyelid Diseases
- Being tested
- Blephasteam
- Keywords
- Meibomian Gland Dysfunction
- Medical subject headings
- Eyelid Diseases, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephasteamDevice
Eye lid warming goggles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christophe Baudouin, Professor, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsFrédéric Chiambaretta, Professor, Principal investigator, University Hospital, Clermont-FerrandSerge Doan, Doctor, Principal investigator, Hopital Bichat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091311
- Sponsor's protocol ID
- LT2420-PIV-CE-01/10
- Other IDs
- N° RCB 2010-A00017-32
- Acronym
- ESPOIR
- Status last verified
- Jun 2011
- First submitted
- 19 Mar 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.
- ClinicalTrials.gov ID
- NCT01091311
- Acronym / sponsor ID
- ESPOIR / LT2420-PIV-CE-01/10
- Conditions
- Eyelid Diseases
- Keywords
- Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlephasteamEye lid warming goggles | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Baudouin, Professor principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Frédéric Chiambaretta, Professor principal investigator
University Hospital, Clermont-Ferrand
Serge Doan, Doctor principal investigator
Hopital Bichat
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blephasteam in people with Eyelid Diseases, run by Laboratoires Thea at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.