Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:45 PM
Study NCT ID:
NCT07422259
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study prospective, interventional, single-blind (assessor-blinded), controlled, of superiority vs a commercial medical device, randomized, and conducted in a single clinical site.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance and Benefit', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through subjective symptomatology expressed according to SANDE.\n\nThe efficacy analysis has been evaluated by:\n\n\\- Change in symptoms measured by a questionnaire (SANDE - Symptom Assessment in Dry Eye) to assess patient well-being.\n\nUnit of Measure: The SANDE is based on a visual analog scale (VAS). The patient answers only two questions regarding the frequency and severity of symptoms. For each question, a 100-millimeter horizontal line is provided: Symptom Frequency: From "Rarely" (0 mm) to "All the Time" (100 mm). Symptom Severity: From "Very Mild" (0 mm) to "Very Severe" (100 mm).\n\nThe final measurement (Final Score) is a numerical value between 0 and 100. The total score is obtained by calculating the square root of the product of the two scales.\n\nParameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days'}, {'measure': 'Clinical Performance and Benefit', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through the Schirmer test.\n\nThe efficacy analysis has been evaluated by:\n\n\\- Schirmer test I (without anesthesia)- quantitative parameter\n\nUnit of Measure: The Schirmer test measures tear production in millimeters (mm) of strip wetting over a set time, typically 5 minutes. Results indicate the length of the moisture strip, with ≤ 5 mm in 5 minutes indicating severe dry eye, while \\>15 mm is considered normal.\n\nParameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days.'}, {'measure': 'Clinical Performance and Benefit', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through the NIK-BUT and BUT.\n\nThe efficacy analysis has been evaluated by:\n\nNon-Invasive Keratograph Break-Up Time (NIKBUT)and BUT, objective, automated metric used in eye care to assess tear film stability.\n\nUnit of measure of NIKBUT: seconds (s). Normal tear film stability usually results in longer NIKBUT values, often exceeding 10 seconds, while dry eye conditions typically present with shorter, faster break-up times.\n\nUnit of measure of BUT: seconds (s). Normal result typically greater than 10 seconds, while values below 10 seconds (or especially under 5 seconds) indicate unstable, evaporative dry eye.\n\nParameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days.'}, {'measure': 'Clinical Performance and Benefit', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through Tear meniscus thickness by keratography.\n\nThe efficacy analysis has been evaluated by:\n\n\\- Tear meniscus thickness by keratograph- quantitative parameter\n\nUnit of Measure: Tear meniscus height (TMH) measured by the Oculus Keratograph 5M (K5M) is reported in millimeters (mm), with normal values typically ranging between 0.2 mm and 0.4 mm.\n\nParameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days.'}, {'measure': 'Clinical Performance and Benefit', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through fluorescein staining and its change between baseline and after 1-2 months of treatment .\n\nThe efficacy analysis has been evaluated by:\n\n\\- Fluorescein staining (NEI scheme - National Eye Institute Industry Workshop)/Corneal/Conjunctival evaluation with fluorescein - ordinal parameter.\n\nUnit of Measure: Subjective, graded scoring systems to assess corneal epithelial damage. The most common unit of measure is the NEI (National Eye Institute) Scale, a 0 to 3 scale for each of the five corneal regions (central, superior, inferior, nasal, temporal), with 0 = no stain and 3 = severe staining in each of 5 areas, based on staining density and location, totaling 0-15 point scale.\n\nParameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days.'}, {'measure': 'Safety/Tolerability', 'timeFrame': 'From enrollment to the end of treatment at 30 and 60 days.', 'description': 'Adverse Events (AEs): Information regarding any medical device (eye drops) defect or event reported by a patient or investigator has been monitored at each investigational visit.\n\nSafety and tolerability analyses have included the number of adverse events occurred during the study in the treatment group and the percentage of patients with at least one adverse event judged to be related to the medical device under study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'The clinical investigation #1122 is a Post Market Clinical Follow Up Study on the EC marked medical device Reinnerva/Lubristil +G, sterile eye drops, compared to Vismed medical device, sterile eye drops, to demonstrate the clinical performance and tolerability of Reinnerva/Lubristil +G to stabilize the lacrimal film and improve the ocular surface condition in the cases of quali-quantitative alterations of the tear film .', 'detailedDescription': 'The study aim was to demonstrate a significant improvement of the ocular surface condition with the use of Reinnerva/Lubristil +G that, based on its formulation: hydrates, stabilizes and protects the ocular surface in all cases of sensations of dryness, burning and ocular fatigue due to qualitative and quantitative alteration of the tear film.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Male and female, aged 18 to 80 years\n* Alteration of the tear film or bilateral ocular surface discomfort resulting from one of the following conditions:\n\nPatients receiving chronic therapy with antihypertensive eye drops; Patients receiving post-ocular surgery therapy for at least 15 days\n\n* At least two of the following symptoms of dry eye: burning, stinging, dry eye sensation, foreign body sensation, photophobia\n* At least two of the following:\n\nSchirmer's test (8 mm lower in 5 minutes) BUT (Burning Time) less than 10 seconds Fluorescein Infection Infection (NEI) score ≥3\n\nExclusion Criteria:\n\n* Active keratitis caused by herpes simplex, vaccinia virus, varicella-zoster, and other viral infections of the cornea and conjunctiva\n* Current bacterial, fungal, and tuberculosis infections\n* Corneal stromal perforations and ulcers\n* Hypersensitivity to any of the product components\n* Current ocular allergy or allergic rhinitis\n* Participation in a clinical trial in the month prior to the start of the study\n* Systemic anti-acne therapy in the 6 months prior to the start of the study\n* Any change in systemic therapy in the month prior to the start of the study\n* Contact lens use in the week prior to the start of the study"}, 'identificationModule': {'nctId': 'NCT07422259', 'briefTitle': 'Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medivis SRL'}, 'officialTitle': 'Tolerability and Efficacy of Reinnerva/Lubristil+G vs Vismed in the Treatment of the Ocular Surface of Patients With Quali-quantitative Alteration of Lacrimal Film of Different Origins', 'orgStudyIdInfo': {'id': '#1122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reinnerva/Lubristil +G', 'description': '25 patients (17 of these participants were post-surgical and 8 glacomatous) received Reinnerva/Lubristil +G, sterile eye drops, 2 drops in 1 eye, twice daily for 60 days .', 'interventionNames': ['Device: Reinnerva/Lubristil +G sterile eye drops (artificial tears)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vismed', 'description': '15 patients (11 of these participants were post-surgical and 4 glacomatous) received Vismed, sterile eye drops, 2 drops in 1 eye, 4 times daily for 60 days .', 'interventionNames': ['Device: Vismed sterile eye drops (artificial tears)']}], 'interventions': [{'name': 'Reinnerva/Lubristil +G sterile eye drops (artificial tears)', 'type': 'DEVICE', 'description': '2 drops instilled in 1 eye, 2 times daily, for 60 days', 'armGroupLabels': ['Reinnerva/Lubristil +G']}, {'name': 'Vismed sterile eye drops (artificial tears)', 'type': 'DEVICE', 'description': '2 drops instilled in 1 eye, 4 times daily, for 60 days', 'armGroupLabels': ['Vismed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'UOC of Ophthalmology, AOU Policlinico "G. Martino"', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared for privacy and confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medivis SRL', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Messina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}