Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04812951
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2021-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms Assessment Questionnaire iN Dry Eye', 'timeFrame': '4 months', 'description': 'SANDE (frequency and severity scores; 0-100)'}, {'measure': 'National Eye Institute grading scale', 'timeFrame': '4 months', 'description': 'NEI corneal staining ( n/15 score; 0-15)'}, {'measure': "Rate of tears' production", 'timeFrame': '4 months', 'description': 'Schirmer test (mm/5min)'}, {'measure': 'Tears Break Up Time', 'timeFrame': '4 months', 'description': 'T-BUT (Seconds)'}], 'secondaryOutcomes': [{'measure': "Biomarkers' expression in conjunctival epithelial cells", 'timeFrame': '4 months', 'description': 'HLA DR (molecular expression)'}, {'measure': "Biomarkers' expression in conjunctival epithelial cells", 'timeFrame': '4 months', 'description': 'ICAM-1 (molecular expression)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ocular surface disease'], 'conditions': ['Ocular Surface Disease', 'Ocular Inflammation']}, 'referencesModule': {'references': [{'pmid': '30078540', 'type': 'BACKGROUND', 'citation': 'Gupta PK, Drinkwater OJ, VanDusen KW, Brissette AR, Starr CE. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Cataract Refract Surg. 2018 Sep;44(9):1090-1096. doi: 10.1016/j.jcrs.2018.06.026. Epub 2018 Aug 2.'}, {'pmid': '27627886', 'type': 'BACKGROUND', 'citation': 'Kim JS, Lee H, Choi S, Kim EK, Seo KY, Kim TI. Assessment of the Tear Film Lipid Layer Thickness after Cataract Surgery. Semin Ophthalmol. 2018;33(2):231-236. doi: 10.1080/08820538.2016.1208764. Epub 2016 Sep 14.'}, {'pmid': '28848324', 'type': 'BACKGROUND', 'citation': "Trattler WB, Majmudar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017 Aug 7;11:1423-1430. doi: 10.2147/OPTH.S120159. eCollection 2017."}, {'pmid': '29504953', 'type': 'BACKGROUND', 'citation': 'Iglesias E, Sajnani R, Levitt RC, Sarantopoulos CD, Galor A. Epidemiology of Persistent Dry Eye-Like Symptoms After Cataract Surgery. Cornea. 2018 Jul;37(7):893-898. doi: 10.1097/ICO.0000000000001491.'}, {'pmid': '29926365', 'type': 'BACKGROUND', 'citation': 'Kohli P, Arya SK, Raj A, Handa U. Changes in ocular surface status after phacoemulsification in patients with senile cataract. Int Ophthalmol. 2019 Jun;39(6):1345-1353. doi: 10.1007/s10792-018-0953-8. Epub 2018 Jun 20.'}, {'pmid': '24265705', 'type': 'BACKGROUND', 'citation': 'Kasetsuwan N, Satitpitakul V, Changul T, Jariyakosol S. Incidence and pattern of dry eye after cataract surgery. PLoS One. 2013 Nov 12;8(11):e78657. doi: 10.1371/journal.pone.0078657. eCollection 2013.'}, {'pmid': '29677365', 'type': 'BACKGROUND', 'citation': 'Micera A, Di Zazzo A, Esposito G, Longo R, Foulsham W, Sacco R, Sgrulletta R, Bonini S. Age-Related Changes to Human Tear Composition. Invest Ophthalmol Vis Sci. 2018 Apr 1;59(5):2024-2031. doi: 10.1167/iovs.17-23358.'}, {'pmid': '30515814', 'type': 'BACKGROUND', 'citation': 'Di Zazzo A, Micera A, De Piano M, Cortes M, Bonini S. Tears and ocular surface disorders: Usefulness of biomarkers. J Cell Physiol. 2019 Jul;234(7):9982-9993. doi: 10.1002/jcp.27895. Epub 2018 Dec 4.'}, {'pmid': '29849499', 'type': 'BACKGROUND', 'citation': 'Olivieri F, Prattichizzo F, Grillari J, Balistreri CR. Cellular Senescence and Inflammaging in Age-Related Diseases. Mediators Inflamm. 2018 Apr 17;2018:9076485. doi: 10.1155/2018/9076485. eCollection 2018. No abstract available.'}, {'pmid': '30156909', 'type': 'BACKGROUND', 'citation': 'Baker JR, Vuppusetty C, Colley T, Hassibi S, Fenwick PS, Donnelly LE, Ito K, Barnes PJ. MicroRNA-570 is a novel regulator of cellular senescence and inflammaging. FASEB J. 2019 Feb;33(2):1605-1616. doi: 10.1096/fj.201800965R. Epub 2018 Aug 29.'}, {'pmid': '29259496', 'type': 'BACKGROUND', 'citation': 'Ventura MT, Casciaro M, Gangemi S, Buquicchio R. Immunosenescence in aging: between immune cells depletion and cytokines up-regulation. Clin Mol Allergy. 2017 Dec 14;15:21. doi: 10.1186/s12948-017-0077-0. eCollection 2017.'}, {'pmid': '25325897', 'type': 'BACKGROUND', 'citation': 'Torricelli AA, Santhiago MR, Wilson SE. Topical cyclosporine a treatment in corneal refractive surgery and patients with dry eye. J Refract Surg. 2014 Aug;30(8):558-64. doi: 10.3928/1081597X-20140711-09.'}, {'pmid': '31022299', 'type': 'BACKGROUND', 'citation': 'Di Zazzo A, Micera A, Coassin M, Varacalli G, Foulsham W, De Piano M, Bonini S. InflammAging at Ocular Surface: Clinical and Biomolecular Analyses in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2019 Apr 1;60(5):1769-1775. doi: 10.1167/iovs.18-25822.'}]}, 'descriptionModule': {'briefSummary': 'Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery', 'detailedDescription': 'To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* Postmenopausal women for whom cataract surgery has been scheduled\n* Stage N2-3; C1-2 according (Lens Opacities classification System) LOCS\n* Willing to sign informed consent and fully participate to all length of the study\n* Patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease\n* Patient with no history of ocular surgery\n* Patients without any previous or concomitant ocular diseases\n\nExclusion Criteria:\n\n* Patients under topical or systemic anti- inflammatory drugs Patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs\n* Patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics)\n* Patients with a history of allergic, congenital, autoimmune systemic diseases\n* Patients who have undergone previous eye surgery\n* Ocular or peri-ocular malignancies or premalignant conditions\n* Active or suspected ocular or peri-ocular infection.\n* Complicated Cataract Surgery\n* Patients with a positive pregnancy testAllergy or reaction history to study drug\n* Patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug'}, 'identificationModule': {'nctId': 'NCT04812951', 'acronym': 'CSA2020', 'briefTitle': 'Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age', 'orgStudyIdInfo': {'id': 'CSA2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'young control', 'description': '25 patients \\< 65 years old without any prophylactic anti-inflammatory preoperative treatment'}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': '25 patients \\> 75 years old without any prophylactic anti-inflammatory preoperative treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': '25 patients \\> 75 years old with prophylactic anti-inflammatory preoperative treatment', 'interventionNames': ['Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vehicle group', 'description': '25 patients \\> 75 years old with vehicle preoperative treatment', 'interventionNames': ['Device: cationorm eye drops']}], 'interventions': [{'name': 'CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion', 'type': 'DRUG', 'otherNames': ['Ikervis eye drops'], 'description': 'one cyclosporine 0.1% eye drop twice a day for 30 preoperative days', 'armGroupLabels': ['Study group']}, {'name': 'cationorm eye drops', 'type': 'DEVICE', 'description': 'one cationorm eye drop twice a day for 30 preoperative days', 'armGroupLabels': ['Vehicle group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'University Campus Bio Medico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '1. Screening visit (-30 days)\n2. Cataract surgery\n3. visit 1 ( 7 days after surgery)\n4. visit 2 (15 days after surgery)\n5. visit 3 (45 days after surgery),\n6. last follow up (90 days after surgery)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Di Zazzo', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}