Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT04673604
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the dosing coordinator is aware of the treatment patients use.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Masked, prospective, placebo-controlled, crossover trial of glaucoma patients with moderate to severe GTR-OSD on preserved latanoprost and dorzolamide/timolol fixed combination therapy for well-controlled open-angle glaucoma was conducted. Patients were randomized to receive preservative-free tafluprost and dorzolamide/timolol fixed combination with either topical placebo or cyclosporine 0.1% for 6 months and will then be crossed over to the opposite therapy. Oxford score of staining will be the primary outcome; osmolarity, matrix-metalloproteinase-9 testing (MMP-9), meibomian gland dysfunction (MGD), adverse events and diurnal intraocular pressure (IOP) comprise the secondary outcomes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in ocular staining (Oxford score)', 'timeFrame': '6 months', 'description': 'The primary efficacy endpoint for this crossover study will be the mean change from baseline in the total ocular staining score as determined by the 15-point Oxford scale of staining on the study eye.'}], 'secondaryOutcomes': [{'measure': 'Mean diurnal IOP', 'timeFrame': '6 months', 'description': 'Mean diurnal intraocular pressure with the two preservative-free therapies versus preserved baseline will be evaluated as secondary endpoint.'}, {'measure': 'Osmolarity', 'timeFrame': '6-months', 'description': 'Mean tear osmolarity with the two PF therapies versus preserved baseline will be evaluated as secondary endpoint.'}, {'measure': 'Matrix-metalloproteinase-9 (MMP-9) over-expression', 'timeFrame': '6 months', 'description': 'Mean MMP-9 over-expression with the two PF therapies versus preserved baseline will be evaluated as secondary endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'There is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen to a preservative-free (PF) one, while employing sufficiently robust OSD metrics. The investigators have therefore carried out a single center, prospective, crossover investigation to compare the 6-month effect of switching well controlled open-angle glaucoma patients with at least moderate glaucoma therapy-related ocular surface disease from preserved to triple preservative-free therapy with and without cyclosporine 0.1% dosed in the evening.', 'detailedDescription': 'Halting and reversing glaucoma therapy-related ocular surface disease (GTR-OSD) will improve the success of long-term medical therapy, impacting millions of patients worldwide. Chronic medical therapy for glaucoma may be immensely benefitted by limiting disabling GTR-OSD, which would aid in the prevention of blindness. In 2015 a novel cationic formulation of cyclosporine A 0.1% was approved with once in the evening dosing in Europe. It is an effective, targeted immunomodulatory compound reducing inflammatory mediators and providing healing of the ocular epithelium. There remains however a paucity of published controlled evidence for GTR-OSD patients treated with this formulation. In addition, there is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen, to a preservative-free one, while employing sufficiently robust OSD metrics. The investigators have therefore carried out a single center prospective, crossover investigation to compare the 6-month effect of switching well controlled open-angle glaucoma patients with at least moderate GTR-OSD, from preserved to triple PF therapy with and without PF cyclosporine 0.1% dosed in the evening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Adult patients with well controlled open-angle glaucoma\n* Patients chronically treated for more than 6 months with preserved, branded, or generic, triple antiglaucoma therapy comprising latanoprost and dorzolamide/timolol fixed combination\n* Subjects should have experienced at least 1 symptom of dry eye (soreness, scratchiness, dryness, grittiness, and burning)\n* Additionally, patients should demonstrate at least one of the objective signs for OSD at baseline: positive conjunctival staining with lissamine green and/or evidence of positive corneal staining with fluorescein (assessed with the 15-point Oxford scale),\n* Patients must show a BUT\\<8 seconds\n* On screening patients should show a Schirmer test without anesthesia (Schirmer-I test) ≥3 and ≤10 mm in 5 minutes.\n* When both eyes qualify the worse eye will be included in the study.\n\nExclusion criteria\n\n* Best corrected visual acuity \\<1/10\n* Patients with severe dry eye disease or Sjogren's disease\n* Presence of eyelid abnormality, corneal disorder or abnormality, ocular surface metaplasia, filamentous keratitis, or corneal neovascularization\n* Patients who have undergone ocular surgery (of any type, including laser surgery), or ocular trauma within 4 months prior to screening\n* Subjects who had punctal occlusion, or diathermy within 3 months prior to screening or abnormality of the nasolacrimal drainage apparatus.\n* Known allergy, or sensitivity to any of the study medications\n* Uncontrolled systemic disease, or history or active signs of ocular trauma, infection, inflammation, allergic disease, or herpes; corneal ulcers; recurrent erosions; or uveitis\n* Female patients will be excluded if they are pregnant, breastfeeding, planning a pregnancy, or are unwilling to use a reliable form of contraception."}, 'identificationModule': {'nctId': 'NCT04673604', 'briefTitle': 'From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Changing From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy: Impact on the Rate and Severity of Ocular Surface Disease', 'orgStudyIdInfo': {'id': '399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Triple preservative-free therapy with placebo in the evening', 'description': 'In this arm subjects will be randomized to topical therapy comprising preservative-free tafluprost drops dosed in the evening (20:30) and dorzolamide/timolol fixed combination drops administered twice daily (8:00 and 20:00). Patients will use placebo (artificial tears) in the evening (21:00) for 6 months. At the end of this period patients will be crossed over to the other therapy (cyclosporine 0.1% in the evening)', 'interventionNames': ['Diagnostic Test: Assessment of ocular surface staining (Oxford score 0-15 scale)', 'Drug: mean diurnal intraocular pressure-lowering']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple preservative-free therapy with cyclosporine 0.1% in the evening', 'description': 'In this arm subjects will be randomized to topical therapy comprising preservative-free tafluprost drops dosed in the evening (20:30) and dorzolamide/timolol fixed combination drops administered twice daily (8:00 and 20:00). Patients will use cyclosporine 0.1% drops in the evening (21:00) for 6 months. At the end of this period all patients will be crossed over to the other therapy (placebo in the evening)', 'interventionNames': ['Diagnostic Test: Assessment of ocular surface staining (Oxford score 0-15 scale)', 'Drug: mean diurnal intraocular pressure-lowering']}], 'interventions': [{'name': 'Assessment of ocular surface staining (Oxford score 0-15 scale)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Corneal and conjunctiva staining will be recorded according to the Oxford grading scheme for ocular staining (0-15 score).', 'armGroupLabels': ['Triple preservative-free therapy with cyclosporine 0.1% in the evening', 'Triple preservative-free therapy with placebo in the evening']}, {'name': 'mean diurnal intraocular pressure-lowering', 'type': 'DRUG', 'description': 'At the end of each 6-month period patients will undergo diurnal intraocular pressure assessment with both therapies.', 'armGroupLabels': ['Triple preservative-free therapy with cyclosporine 0.1% in the evening', 'Triple preservative-free therapy with placebo in the evening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55536', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'University Department of Ophthalmology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Andreas Katsanos, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Ioannina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Ophthalmology', 'investigatorFullName': 'AGP Konstas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}