Eyelid DiseasesPhase 4ESPOIR ExtNCT01189474
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 29 sites in France.
Trial summary
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. 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
- 104 participants
- Where
- 29 sitesFrance
- Study dates
- Jun 2010to Dec 2011
- 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
29 sites in 1 country.
29 sites in 1 country
France29 sites
CHU d'Amiens
Amiens, 80054
Hopital Pellegrin
Bordeaux, 33000
CHU de Dijon
Dijon, 21000
76 Allée des Pins Tranquilles
Hossegord, 40150
CHU de Bicêtre
Le Kremlin Bicêtre, 94270
Hopital Claude Huriez
Lille, 59000
Hopital Dupuytren
Limoges, 87042
Hopital Edouard Heriot
Lyon, 69000
433 bis rue Paradis
Marseille, 13000
Hopital d'instruction des armées LAVERAN
Marseille, 13000
67 chemin du Fescau
Montferrier-sur-Lez, 34980
60 place Jacques Mirouze
Montpellier, 34000
3 cours Leopold
Nancy, 54000
Hopital Max Fourestier
Nanterre, 92014
4 avenue Baquis
Nice, 06000
Centre Hospitalier de Nimes
Nîmes, 30029
22 rue Beaujon
Paris, 75000
Hotel Dieu
Paris, 75000
C.H.N.O des XV-XX
Paris, 75012
142 Boulevard de Montparnasse
Paris, 75014
Fondation Rothschild
Paris, 75019
26 rue du Moulin des justices
Puilboreau, 17138
Polyclinique Saint Laurent
Rennes, 35000
CHU de Saint Etienne
Saint-Etienne, 42000
CHU Hospices Civils
Strasbourg, 67000
Hôpital de Tarbes
Tarbes, 65013
Clinique du Cours Dillion
Toulouse, 31300
CHU Bretonneau
Tours, 37044
Hopital Brabois Adulte
Vandœuvre-lès-Nancy, 54505
About this study
Official title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.
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.
- 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 posted26 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Paul ADENIS, Professor, Principal investigator, Hopital Dupuytren LimogesIsabelle BADELLON, Doctor, Principal investigator, Fondation Rothschild ParisVincent BORDERIE, Professor, Principal investigator, CHNO des quinze-vingtsTristan BOURCIER, Professor, Principal investigator, CHU de StrasbourgJean Louis BOURGES, Doctor, Principal investigator, Hotel Dieu ParisDominique BREMOND GIGNAC, Professor, Principal investigator, Centre Hospitalier Universitaire, AmiensCarole BURILLON, Professor, Principal investigator, Hopital Edouard Heriot LyonPhilippe CAZEMIND, Doctor, Principal investigator, Clinique du cours Dillion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189474
- Sponsor's protocol ID
- LT2420-PIV-CE-02/10
- Other IDs
- N° RCB 2010-A00199-30
- Acronym
- ESPOIR Ext
- Status last verified
- Oct 2012
- First submitted
- 25 Aug 2010
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.
- ClinicalTrials.gov ID
- NCT01189474
- Acronym / sponsor ID
- ESPOIR Ext / LT2420-PIV-CE-02/10
- Conditions
- Eyelid Diseases
- Keywords
- Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Aug 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 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.
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 3 Oct 2012.
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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.
Jean Paul ADENIS, Professor principal investigator
Hopital Dupuytren Limoges
Isabelle BADELLON, Doctor principal investigator
Fondation Rothschild Paris
Vincent BORDERIE, Professor principal investigator
CHNO des quinze-vingts
29 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 29 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 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 3 Oct 2012.