protocolSection identificationModule nctId: NCT06317922, orgStudyIdInfo id: DRYEYE-IVT Project, briefTitle: Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections, acronym: DRYEYE-IVT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-05-12, completionDateStruct date: 2025-05-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Francesco Bandello, class: OTHER, descriptionModule briefSummary: The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.The main questions it aims to answer are:* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?Each participant will be randomized into each of two arms:1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.In any case, the instillation of saline solution should not alter the ocular surface., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: There are two teams:1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks:   * dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate);   * accountability of Investigational medical device and saline solution;   * verify the compliance and therapeutic adherence of the patient;   * discussion with the patient regarding the respect of the masked condition of the study;2. UNMASKED TEAMS:   * informed consent process;   * to perform the follow-up visit and assessments provided to test the ocular surface., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Thealoz Duo;, interventions name: sham (Hydrabak), outcomesModule primaryOutcomes measure: Administration of Ocular Surface Disease Index (OSDI) to the patient, secondaryOutcomes measure: administration of Visual Analog Scale for Pain to the patient, secondaryOutcomes measure: evaluation of matrix metalloproteinase 9 gene expression, secondaryOutcomes measure: TearLab Osmolarity, secondaryOutcomes measure: Schirmer's test, secondaryOutcomes measure: tear film Break Up Time (tBUT), secondaryOutcomes measure: conjunctival hyperemia according to Efron grading scale, secondaryOutcomes measure: fluorescein staining, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele _O.U. Ophthalmology, status: RECRUITING, city: Milan, zip: 20123, country: Italy, contacts name: Giulia Basile, MPharm, role: CONTACT, phone: +39 0226433545, email: basile.giulia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False