Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-05 @ 6:51 PM
Study NCT ID:
NCT04020705
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2019-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glaucomatous damage', 'timeFrame': 'Baseline and Visit at 36 months', 'description': 'The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.'}], 'secondaryOutcomes': [{'measure': 'progression of glaucoma in the SD OCT examination', 'timeFrame': 'Baseline and Visit at 36 months', 'description': 'assessment of the progression of glaucoma in the SD OCT examination (Retinal Nerve fiber Layer- RNFL evaluation) in the group that receives the topical citicoline together with ocular antihypertensive drug therapy compared to the group treated with the sole reduction of intraocular pressure.\n\nIt will be used for the assessment of the progression of glaucoma the Brusini staging system.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Glaucoma Open Angle', 'Pseudoexfoliation Glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.\n\nPatients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.\n\nAll patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).\n\nThe primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).\n\nThe secondary objective is to assess the tolerability and safety of OMK1 eye drops.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.\n* Patients with -2 \\< MD \\< -15 dB, progression of MD at least -0,5 dB/y for 2 years.\n* Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.\n* Patients over the age of 18 years\n\nExclusion Criteria:\n\n* Patients with contraindications to citicoline\n* Patients with IOP higher than 18 mmHg\n* Patients with other forms of glaucoma\n* Patients treated with other neuroprotective therapies\n* Women who are pregnant and/or breastfeeding\n* Pediatric or adolescent patients aged under 18 years'}, 'identificationModule': {'nctId': 'NCT04020705', 'briefTitle': 'The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma', 'organization': {'class': 'NETWORK', 'fullName': 'Istituto di Ricerca Neuroftalmologia S.r.l.'}, 'officialTitle': 'The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma', 'orgStudyIdInfo': {'id': 'OMK20115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citicoline eye drops (OMK1)', 'description': '45 patients will be treated with active treatment (OMK1)', 'interventionNames': ['Device: Citicoline eye drops (OMK1)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'hypromellose based ocular lubricant', 'description': '45 patients will be treated with placebo (lubricant eye drops)', 'interventionNames': ['Other: Placebo Comparator: hypromellose based ocular lubricant']}], 'interventions': [{'name': 'Citicoline eye drops (OMK1)', 'type': 'DEVICE', 'description': '(OMK1) will be prescribed in the dosage of 1 drop 3 times a day', 'armGroupLabels': ['Citicoline eye drops (OMK1)']}, {'name': 'Placebo Comparator: hypromellose based ocular lubricant', 'type': 'OTHER', 'description': 'will be prescribed in the dosage of 1 drop 3 times a day', 'armGroupLabels': ['hypromellose based ocular lubricant']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto di Ricerca Neuroftalmologia S.r.l.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Clinical Ophthalmologist P.O. San Paolo Milan', 'investigatorFullName': 'Luca Rossetti', 'investigatorAffiliation': 'University of Milan'}}}}