Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-26 @ 5:39 PM
Study NCT ID:
NCT03442751
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'VSmith@glaukos.com', 'phone': '9493679600', 'title': 'Valerie Smith', 'organization': 'Glaukos'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months for the Epithelium-on CXL Treatment Group and 6 months for the Sham Treatment/Control Group', 'description': 'For the ocular adverse event arms, the affected and at risk population reflect the number of eyes.\n\nFor the non-ocular adverse event arms, the affected and at risk population reflect the number of participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Ocular: Epithelium-on CXL Treatment Group', 'description': 'Study eye received riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 170, 'seriousNumAtRisk': 189, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ocular: Sham Treatment/Control Group', 'description': 'Sham eye received Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 63, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-ocular: Epithelium-on', 'description': 'Participant eye(s) treated only with this intervention (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System)', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 1, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Non-ocular: Sham Treatment/Control', 'description': 'Participant eye(s) treated only with this intervention (i.e., Placebo \\[the vehicle of riboflavin ophthalmic solution\\] and Mock UVA light source)', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Non-ocular: Epithelium-on and Sham Treatment', 'description': 'Participant had one eye treated with Epithelium-on CXL (i.e., riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System) and one eye treated with Sham (i.e., Placebo \\[the vehicle of riboflavin ophthalmic solution\\] and Mock UVA light source)', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 120, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal opacity', 'notes': 'corneal haze', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 97, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 90, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 84, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 70, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 66, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal striae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anterior chamber flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal warpage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal thinning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vital dye staining cornea present', 'notes': 'corneal fluorescein staining', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Corneal opacity', 'notes': 'posterior stromal haze post-operatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epithelium-on CXL Treatment Group', 'description': 'Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System\n\nRiboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System'}, {'id': 'OG001', 'title': 'Sham Treatment/Control Group', 'description': 'Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source\n\nPlacebo KXL High Power System providing mock UVA light source'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.0'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.4', 'groupDescription': 'Repeated measures mixed analysis of covariance model', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 months', 'description': 'Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups', 'unitOfMeasure': 'Diopters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed using multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epithelium-on CXL Treatment Group', 'description': 'Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System\n\nRiboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System'}, {'id': 'OG001', 'title': 'Sham Treatment/Control Group', 'description': 'Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source\n\nPlacebo KXL High Power System providing mock UVA light source'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.6', 'groupDescription': 'repeated measures mixed analysis of covariance model', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'last observation carried forward was used to impute missing Month 12 data'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax', 'unitOfMeasure': 'Diopters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epithelium-on CXL Treatment Group', 'description': 'Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System Riboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System'}, {'id': 'FG001', 'title': 'Sham Treatment/Control Group', 'description': 'Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source\n\nPlacebo KXL High Power System providing mock UVA light source'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '189', 'numSubjects': '156'}, {'groupId': 'FG001', 'numUnits': '90', 'numSubjects': '83'}]}, {'type': 'Month 6', 'achievements': [{'groupId': 'FG000', 'numUnits': '186', 'numSubjects': '153'}, {'groupId': 'FG001', 'numUnits': '89', 'numSubjects': '82'}]}, {'type': 'Month 12', 'achievements': [{'groupId': 'FG000', 'numUnits': '183', 'numSubjects': '150'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '183', 'numSubjects': '150'}, {'groupId': 'FG001', 'numUnits': '89', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Subjects were recruited at eye clinics and were required to meet inclusion/exclusion criteria prior to enrollment', 'preAssignmentDetails': '280 eyes of 201 subjects were randomized in a 2:1 treatment allocation. Of the 280 randomized eyes, 279 were treated: 189 eyes of 156 subjects received CXL treatment \\& 90 eyes of 83 subjects received Sham/Control, for a total of 239 treatments. Of the 201 unique subjects, 118 received CXL only (in 1 or both eyes), 45 received Sham/Control only (in 1 or both eyes), and 38 subjects received CXL in 1 eye and Sham/Control in the other eye.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Epithelium-on CXL Treatment Group', 'description': 'Study eye receives riboflavin ophthalmic solution A, riboflavin ophthalmic solution B and irradiated using KXL High Power System\n\nRiboflavin Ophthalmic Solution A Riboflavin Ophthalmic Solution B: KXL High Power System'}, {'id': 'BG001', 'title': 'Sham Treatment/Control Group', 'description': 'Sham eye receives Placebo (the vehicle of Riboflavin Ophthalmic Solution) and Mock UVA light source\n\nPlacebo KXL High Power System providing mock UVA light source'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '9.75', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '30.0', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity: Hispanic or Latino', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity: Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Race: Black or African American', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Race: Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Race: White', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Mean Kmax (D)', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Kmax = maximal corneal curvature of the study eye(s)', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Subjects with progressive keratoconus in at least one eye (study eye). Subjects may contribute more than one eye if both eyes qualify. Eyes vs. subjects were randomized to the treatment arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-11', 'size': 4922538, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-22T00:14', 'hasProtocol': True}, {'date': '2020-12-09', 'size': 1338771, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-20T19:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2020-12-16', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2018-02-16', 'resultsFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2018-02-16', 'dispFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-29', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax', 'timeFrame': '6 months', 'description': 'Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups'}], 'secondaryOutcomes': [{'measure': 'Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax', 'timeFrame': '12 months', 'description': 'Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Progressive Keratoconus']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.', 'detailedDescription': 'Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change in Kmax from baseline to Month 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be between 12 and 55 years of age, male or female, of any race;\n2. Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as having a parent or legal guardian sign an informed consent\n3. Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire;\n4. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;\n5. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of each study eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);\n6. Having topographic and clinical evidence of keratoconus\n\nExclusion Criteria:\n\n1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;\n2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;\n3. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.\n4. A history of delayed epithelial healing in the eye to be treated or a current condition that may interfere with or prolong epithelial healing;\n5. A history of previous corneal cross-linking treatment in the eye to be treated;\n6. Have used an investigational drug or device within 30 days of screening or be concurrently enrolled in another investigational drug or device trial within 30 days of the study.'}, 'identificationModule': {'nctId': 'NCT03442751', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus', 'orgStudyIdInfo': {'id': 'ACP-KXL-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epithelium-on CXL Treatment Group', 'description': 'Study eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system', 'interventionNames': ['Drug: Test Article A', 'Drug: Test Article B', 'Device: KXL medical device system']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Treatment/Control Group', 'description': 'Sham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system', 'interventionNames': ['Drug: Placebo', 'Device: KXL medical device system']}], 'interventions': [{'name': 'Test Article A', 'type': 'DRUG', 'description': 'Riboflavin Ophthalmic Solution A', 'armGroupLabels': ['Epithelium-on CXL Treatment Group']}, {'name': 'Test Article B', 'type': 'DRUG', 'description': 'Riboflavin Ophthalmic Solution B', 'armGroupLabels': ['Epithelium-on CXL Treatment Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Vehicle of Test Article', 'armGroupLabels': ['Sham Treatment/Control Group']}, {'name': 'KXL medical device system', 'type': 'DEVICE', 'description': 'Mock UVA light source', 'armGroupLabels': ['Sham Treatment/Control Group']}, {'name': 'KXL medical device system', 'type': 'DEVICE', 'description': 'Cross-linking UVA light source', 'armGroupLabels': ['Epithelium-on CXL Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'overallOfficials': [{'name': 'Valerie Smith', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}