Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

Corticosteroid Clinical Trial

— KALICORT  

Official title:

Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107246
• Other study ID #: 19CH145
• Secondary ID: 2019-A02280-57
• Status: Completed
• Start date: November 20, 2019
• Est. completion date: October 22, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Corneal Graft Disorder (Disorder)
• Corticosteroid

Intervention

Device:
• use of the KaliJAR box
KaliJAR® : validated device for single-dose eye drops collection. the patient will be asked to discard each single dose of eye drops in the KaliJAR box. The patient returns with the KaliJAR box at each consultation as part of normal practice. The KaliJAR box will be emptied at each consultation by the doctor and then returned to the patient. No further examination or visit.

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Kali Care

Country where clinical trial is conducted

France, 

Outcome

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