protocolSection identificationModule nctId: NCT06323395, orgStudyIdInfo id: JGL-DED-VIZ-SLB 21, briefTitle: Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Jadran Galenski laboratorij d.d., class: INDUSTRY, collaborators name: Poseidon CRO, descriptionModule briefSummary: The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Vizol S LIPID BALANCE eye drops, interventions name: ophthalmic saline eye drops, outcomesModule primaryOutcomes measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15), secondaryOutcomes measure: percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30), otherOutcomes measure: The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period, otherOutcomes measure: BCVA, otherOutcomes measure: Frequency of ocular signs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Special eye hospital - Beogradski oftalmološki centar, city: Belgrad, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Specialized clinic for eye desease - klinika Veselinović, city: Niš, zip: 18000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, hasResults: False