Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-05-17 @ 9:51 PM
Study NCT ID:
NCT04062435
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Uptake of Riboflavin Eye Drops
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative changes in anterior chamber riboflavin concentrations over a time period of 60 min for both application sites (inferior fornix and cornea)', 'timeFrame': 'Three hours', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cross-linking, Riboflavin, Fluorophotometry, FluorotronTM Master'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy clinical staff members of the Dept. of Ophthalmology at the Lucerne Cantonal Hospital will be evaluated for study inclusion.\n* Signed written informed consent form\n\nExclusion Criteria:\n\n* Aged \\< 18 years\n* Any ocular or systemic diseases with ocular side effects\n* Medication with potential ocular side effects\n* Epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration'}, 'identificationModule': {'nctId': 'NCT04062435', 'briefTitle': 'Corneal Uptake of Riboflavin Eye Drops', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'Corneal Uptake of Riboflavin Eye Drops', 'orgStudyIdInfo': {'id': 'KCI_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Group', 'description': 'Peschke®TE 0.25 % application in the INFERIOR FORNIX\n\nPeschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.', 'interventionNames': ['Drug: Drop application in the inferior fornix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Peschke®TE 0.25 % application on the CORNEA\n\nPeschke®TE 0.25 % (Peschke Trade, Hünenberg, Switzerland) eye drops, 1 drop every 5 minutes over 60 minutes by the Principal Investigator.', 'interventionNames': ['Drug: Drop application on the cornea']}], 'interventions': [{'name': 'Drop application in the inferior fornix', 'type': 'DRUG', 'description': 'See Arms', 'armGroupLabels': ['Interventional Group']}, {'name': 'Drop application on the cornea', 'type': 'DRUG', 'description': 'See Arms', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6004', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Dept. of Ophthalmology, Lucerne Cantonal Hospital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Katja Iselin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Ophthalmology, Lucerne Cantonal Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katja Iselin', 'investigatorAffiliation': 'Luzerner Kantonsspital'}}}}