Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 8:45 AM
Study NCT ID:
NCT05865457
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signs', 'timeFrame': 'Day 28', 'description': 'Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': 'Day 28', 'description': 'Change from baseline in Ocular Surface Disease Index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:\n\n* Is BUFY02 non-inferior to TRB02 in terms of signs of DED?\n* Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED?\n\nParticipants will be asked to:\n\n* Visit the trial site at 4 different timepoints\n* Use the allocated study treatment everyday until the end of the study (during 3 months)\n* Be examined by the investigator\n* Complete several questionnaires\n* Return unused study treatment.\n\nResearchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria include:\n\n* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;\n* At least one eye with Oxford score ≥ 4 and ≤ 9;\n* At least one objective sign of tear deficiency (in at least one eligible eye);\n* Having a health insurance.\n\nExclusion Criteria include:\n\n* Wear of contact lenses starting within the last 2 months;\n* Best-corrected visual acuity (BCVA) \\< 1/10;\n* Severe DED with one of the listed conditions:\n* Severe blepharitis;\n* Seasonal allergy;\n* Any issues of the ocular surface not related to DED;\n* History of ocular trauma, infection or inflammation not related to DED;\n* History of ocular surgery, including laser surgery;\n* Unstable glaucoma;\n* Use of artificial tears with preservative within the last 2 weeks;\n* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:\n* Known hypersensitivity to any constituent of the study treatments;\n* Pregnancy or breastfeeding;\n* Participation in another clinical study within the last 90 days;\n* Legally restricted autonomy, freedom of decision and action.'}, 'identificationModule': {'nctId': 'NCT05865457', 'acronym': 'BUSTON-02', 'briefTitle': 'Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'TRB Chemedica International SA'}, 'officialTitle': 'Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation', 'orgStudyIdInfo': {'id': 'BUFY02-CT-2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BUFY02', 'description': '0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL', 'interventionNames': ['Device: BUFY02 eye drops in single-dose containers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRB02', 'description': '0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL', 'interventionNames': ['Device: TRB02 eye drops in single-dose containers']}], 'interventions': [{'name': 'BUFY02 eye drops in single-dose containers', 'type': 'DEVICE', 'description': '1 to 2 drops in each eye, as often as needed', 'armGroupLabels': ['BUFY02']}, {'name': 'TRB02 eye drops in single-dose containers', 'type': 'DEVICE', 'description': '1 to 2 drops in each eye, as often as needed', 'armGroupLabels': ['TRB02']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Jutta Horwath-Winter, Dr', 'role': 'CONTACT', 'email': 'jutta.horwath@medunigraz.at', 'phone': '+43 316 385 80807'}], 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stefan Palkovits, Dr', 'role': 'CONTACT', 'email': 'stefan.palkovits@oegk.at', 'phone': '+43 1 91 021 57573'}], 'facility': 'VIROS', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Beatrice Cochener, Prof.', 'role': 'CONTACT', 'email': 'beatrice.cochener@univ-brest.fr', 'phone': '+33 2 98 22 34 40'}], 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Labetoulle', 'role': 'CONTACT', 'email': 'marc.labetoulle@aphp.fr', 'phone': '+33 1 45 21 36 90'}], 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie Baillif, Prof.', 'role': 'CONTACT', 'email': 'baillif.s@chu-nice.fr', 'phone': '+33 4 92 03 8025'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TRB Chemedica International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}