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

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.

Study Overview

• Status: Completed
• Conditions: Corticosteroid; Corneal Graft Disorder (Disorder)
• Intervention / Treatment: Device: use of the KaliJAR box

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newly transplanted corneal patients and adult

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Newly transplanted corneal patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio between the number of instilled drops / number of prescribed drops	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient behaviour towards corticosteroid treatment	Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time	12 months
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Kali Care
• Investigators: Principal Investigator: Philippe GAIN, MD PhD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): October 7, 2020
• Study Completion (Actual): October 22, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19CH145; 2019-A02280-57 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No