Corticosteroid Clinical Trial
— KALICORTOfficial title:
Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops
Verified date | February 2022 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft. Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 22, 2021 |
Est. primary completion date | October 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Newly transplanted corneal patients - Patients able to instill correctly topical corticosteroid treatment - Patients able to come to control visits - Patient affiliated or entitled to a social security system - Patient informed about the study and having signed a consent Exclusion Criteria: - Patients under guardianship - Patients unable to give their consent or to correctly use the collection box |
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint Etienne | Saint Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Kali Care |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio between the number of instilled drops / number of prescribed drops | 12 months | ||
Secondary | patient behaviour towards corticosteroid treatment | Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time | 12 months | |
Secondary | Questionnaire on therapeutic compliance | Morisky questionnaire :
Adherence to treatment is good if the score is greater than or equal to 8. Adherence to treatment is average if the score is 6 or 7. Adherence to treatment is low if the score is less than 6. |
month 1, month 6 and month 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05160441 -
Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis
|
Phase 3 | |
Recruiting |
NCT03365141 -
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
|
N/A | |
Recruiting |
NCT05160506 -
Corticosteroids to Treat Pancreatitis
|
Phase 2 | |
Not yet recruiting |
NCT05059873 -
Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels
|
Phase 4 | |
Not yet recruiting |
NCT05750797 -
The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
|
||
Withdrawn |
NCT05133635 -
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
|
Phase 4 | |
Recruiting |
NCT05230667 -
Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder
|
N/A | |
Not yet recruiting |
NCT05742061 -
Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients
|
Early Phase 1 |