KeratoconusNCT04062435
Corneal Uptake of Riboflavin Eye Drops
A study testing Drop application in the inferior fornix and Drop application on the cornea in people with Keratoconus, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Drop application in the inferior fornix and Drop application on the cornea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Ophthalmology, Lucerne Cantonal Hospital
Lucerne, 6004
About this study
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- Drop application in the inferior fornix, Drop application on the cornea
- Keywords
- Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drop application in the inferior fornixDrug
See Arms
Drop application on the corneaDrug
See Arms
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | 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. Receives: Drug: Drop application in the inferior fornix |
| Control Group | Active comparator | 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. Receives: Drug: Drop application on the cornea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Dec 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Iselin, Luzerner Kantonsspital
- Investigators
- Katja Iselin, MD, Principal investigator, Dept. of Ophthalmology, Lucerne Cantonal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062435
- Sponsor's protocol ID
- KCI_02
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Uptake of Riboflavin Eye Drops
- ClinicalTrials.gov ID
- NCT04062435
- Acronym / sponsor ID
- KCI_02
- Conditions
- Keratoconus
- Keywords
- Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Drug: Drop application in the inferior fornixPeschke®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. |
| Control Group | Active comparator | Drug: Drop application on the corneaPeschke®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drop application in the inferior fornixSee Arms | Drug | Interventional Group |
| Drop application on the corneaSee Arms | Drug | Control Group |
Primary outcome
Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)
Time frame: Three hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Iselin, MD principal investigator
Dept. of Ophthalmology, Lucerne Cantonal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drop application in the inferior fornix and Drop application on the cornea in people with Keratoconus, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea) (time frame: Three hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.