Corneal Uptake of Riboflavin Eye Drops

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Drug: Drop application in the inferior fornix; Drug: Drop application on the cornea

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6004
    • Dept. of Ophthalmology, Lucerne Cantonal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; 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.	Drug: Drop application in the inferior fornix; See Arms
Active Comparator: Control Group; 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.	Drug: Drop application on the cornea; See Arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three hours

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Katja Iselin, MD, Dept. of Ophthalmology, Lucerne Cantonal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: KCI_02

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
• product manufactured in and exported from the U.S.: No