Corneal Uptake of Riboflavin Eye Drops
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Drop application in the inferior fornix
Drop application on the cornea
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
Eligibility Criteria
Inclusion Criteria:
- Healthy clinical staff members of the Dept. of Ophthalmology at the Lucerne Cantonal Hospital will be evaluated for study inclusion.
- Signed written informed consent form
Exclusion Criteria:
- Aged < 18 years
- Any ocular or systemic diseases with ocular side effects
- Medication with potential ocular side effects
- Epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration
Sites / Locations
- Dept. of Ophthalmology, Lucerne Cantonal Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional Group
Control Group
Arm Description
Peschke®TE 0.25 % application in the INFERIOR FORNIX Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.
Peschke®TE 0.25 % application on the CORNEA Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.
Outcomes
Primary Outcome Measures
Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)
Correlating to our standard CXL protocol, the application phase lasts 60 min and the riboflavin drops will be applied by the principle investigator every 5 minutes on the cornea in the conventional and in the inferior fornix in the interventional group. The drop application will be performed in an upright position and without an eyelid speculum. During the application phase, fluorophotometric measurements will be repeated every 15 minutes and changes in corneal and anterior chamber riboflavin concentrations will be documented.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04062435
Brief Title
Corneal Uptake of Riboflavin Eye Drops
Official Title
Corneal Uptake of Riboflavin Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall objective of this study is to optimise the corneal cross-linking standard protocol in terms of a more economical use of the resource "medical personnel" and in terms of increased patient participation. If it can be shown that the riboflavin necessary for corneal cross-linking does not necessarily have to be applied directly on the cornea (as currently performed by the nurses), but can also be applied in the inferior fornix (as it would be performed by patients in the context of self-application), then it would be conceivable to transfer this task from medical staff to the patients.
Detailed Description
This national single-centre, experimental, randomized and controlled trial will comprise two parallel arms. The intervention to be studied will be an alternative application of riboflavin drops in the inferior fornix. As comparator serves a conventional riboflavin drop application directly on the center of the cornea. Our research hypothesis is that the application of riboflavin drops in the inferior fornix is not inferior to the corneal application with respect to the resulting riboflavin concentrations in the anterior chamber; which represents a sufficient corneal impregnation with riboflavin. This study is randomized but not blinded. Recruitment is anticipated to start in September 2019 and is scheduled to last 1-2 months. We will enroll 12 patients in each trial arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Peschke®TE 0.25 % application in the INFERIOR FORNIX
Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Peschke®TE 0.25 % application on the CORNEA
Peschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.
Intervention Type
Drug
Intervention Name(s)
Drop application in the inferior fornix
Intervention Description
See Arms
Intervention Type
Drug
Intervention Name(s)
Drop application on the cornea
Intervention Description
See Arms
Primary Outcome Measure Information:
Title
Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)
Description
Correlating to our standard CXL protocol, the application phase lasts 60 min and the riboflavin drops will be applied by the principle investigator every 5 minutes on the cornea in the conventional and in the inferior fornix in the interventional group. The drop application will be performed in an upright position and without an eyelid speculum. During the application phase, fluorophotometric measurements will be repeated every 15 minutes and changes in corneal and anterior chamber riboflavin concentrations will be documented.
Time Frame
Three hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy clinical staff members of the Dept. of Ophthalmology at the Lucerne Cantonal Hospital will be evaluated for study inclusion.
Signed written informed consent form
Exclusion Criteria:
Aged < 18 years
Any ocular or systemic diseases with ocular side effects
Medication with potential ocular side effects
Epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Iselin, MD
Organizational Affiliation
Dept. of Ophthalmology, Lucerne Cantonal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Ophthalmology, Lucerne Cantonal Hospital
City
Lucerne
ZIP/Postal Code
6004
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Corneal Uptake of Riboflavin Eye Drops
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