Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04485533
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Break-Up Time (TBUT)', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).'}], 'secondaryOutcomes': [{'measure': 'Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Stability of the tear film'}, {'measure': 'Functional Visual Acuity (FVA)', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Functional Visual Acuity (FVA)'}, {'measure': 'Tear secretion', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Tear secretion'}, {'measure': 'Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Burning, foreign body sensation, itching, and photophobia symptoms of DED.\n\n(VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).'}, {'measure': 'Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation'}, {'measure': 'Corneal inflammation assessed by staining grade with SICCA Scale', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation'}, {'measure': 'Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL'}, {'measure': 'Each of the three modules that are part of IDEEL questionnaire', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': 'To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Each of the three modules that are part of IDEEL questionnaire'}, {'measure': 'Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way', 'timeFrame': 'through study completion, an average of 2.5 months', 'description': "To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Medical devices' safety and tolerability:\n\n* Allergy to any device compound\n* Any other adverse event (AE)\n* Adverse device effects (ADEs) -Undetected/unforeseen manufacturing ADE which might bring to application procedure errors -\n* Contamination of the device nozzle and possibility to contaminate both eyes\n* Interaction with any other permitted local administered therapy\n* Vital signs: blood pressure (BP), heart rate (HR), respiratory rate (RR)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).', 'detailedDescription': 'The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator.\n\nPatients, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted.\n\nBaseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment.\n\nBetween V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic evaluations listed in the Flow-Chart will be performed on both eyes of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient Informed consent form (ICF) signed.\n* Males and Females aged ≥18 years at the time of the signature of ICF.\n* Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment.\n* No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions.\n* TBUT value \\<6 sec.\n* Willing to follow all study procedures, including attending all site visits, tests and examinations.\n* Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.\n\nExclusion Criteria:\n\n* Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively).\n* Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment.\n* No previous history or presence of any disease involving cornea or conjunctiva.\n* Sjӧgren syndrome.\n* History or active cicatricial conjunctivitis.\n* History of ocular surface burns.\n* Use of contact lenses.\n* Corneal refractive surgery 1 year post-operative.\n* Any ocular surgery in the previous 3 months preceding the study.\n* Unstable glaucoma (treatment changes in the last year).\n* Any macular or retinal disease that could impact visual acuity.\n* Best corrected visual acuity (BCVA) below 20/40.\n* Blepharitis treatment started less than 3 months before enrolment.\n* Neurological, neurodegenerative or cerebrovascular conditions.\n* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.\n* Unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers.\n* Known hypersensitivity to one of the administered products.\n* Known drug and/or alcohol abuse.\n* Mental incapacity that precludes adequate understanding or cooperation.\n* Participation in another investigational study or blood donation within 1 month prior to ICF signature.'}, 'identificationModule': {'nctId': 'NCT04485533', 'briefTitle': 'Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED', 'organization': {'class': 'INDUSTRY', 'fullName': 'VISUfarma SpA'}, 'officialTitle': 'Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study', 'orgStudyIdInfo': {'id': 'VF-OS-004/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VisuXL® Gel/HYLO®', 'description': 'Patients treated with VisuXL® ophthalmic gel for the first 30 days (1 treatment period) and with HYLO® for the second 30 days (2 treatment period).', 'interventionNames': ['Device: VisuXL® Gel', 'Device: HYLO®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HYLO®/VisuXL® Gel', 'description': 'Patients treated with HYLO® for the first 30 days (1 treatment period) and with VisuXL® ophthalmic gel for the second 30 days (2 treatment period).', 'interventionNames': ['Device: VisuXL® Gel', 'Device: HYLO®']}], 'interventions': [{'name': 'VisuXL® Gel', 'type': 'DEVICE', 'description': 'VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose.\n\nDose/dosage: 1 drop per eye twice a day.', 'armGroupLabels': ['HYLO®/VisuXL® Gel', 'VisuXL® Gel/HYLO®']}, {'name': 'HYLO®', 'type': 'DEVICE', 'description': 'HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water.\n\nDose/dosage: 1 drop per eye twice a day', 'armGroupLabels': ['HYLO®/VisuXL® Gel', 'VisuXL® Gel/HYLO®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'state': 'Finistère', 'country': 'France', 'facility': 'Hôpital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '20142', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'ASST-Santi Paolo e Carlo-Presidio San Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VISUfarma SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}