Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED

Interventional, Multi-center, Randomized, Controlled, Open Label Clinical Investigation Between the Topical Administration of a Tear Substitute Containing Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) Versus Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe Dry Eye Syndrome

The goal of this clinical investigation plan is to evaluate the performance, tolerability, safety, and compliance of an ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV_01) compared with hyaluronic acid 0.3% alone in adult men and women (≥18 years) with moderate-to-severe dry eye syndrome.

The main questions it aims to answer are:

• Is the ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid non-inferior in improving the clinical performance outcomes of dry eye compared with hyaluronic acid alone?
• Is the investigational device safe and well tolerated, with acceptable partecipant compliance over the treatment period?

Researchers will compare the medical device containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV_01) to hyaluronic acid 0.3% alone to see if the combination provides at least equivalent clinical benefit without increased safety issues.

Participants will be randomly assigned (1:1) to one of two treatment groups in a multicenter, prospective, randomized, open-label, controlled study. Participants will instill 1 drop in both eyes 4 times daily (every 4 ± 1 hours) for 30 ± 4 days and attend study visits for assessments of dry eye signs and symptoms, safety, tolerability, and treatment compliance. The study plans to enroll 74 partecipants, with an enrollment period of about 11 months and a total study duration of approximately 12 months (from first partecipant first visit to last partecipant last visit).

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes; Dry Eye Disease (DED)
• Intervention / Treatment: Device: FBV_01; Device: HYLO-VISION® SafeDrop® Gel

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valeria Ipavec; Phone Number: +39 340 3518447; Email: vipavec@fb-vision.it

Study Locations

• Italy
  • CA
    • Cagliari, CA, Italy, 09124
      • Recruiting
      • S.C. di Oculistica Azienda Ospedaliero-Universitaria di Cagliari Presidio San Giovanni di Dio
      • Contact: Giuseppe Giannaccare; Phone Number: +39070 51092148; Email: giuseppe.giannaccare@unica.it
      • Principal Investigator: Giuseppe Giannaccare
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Recruiting
      • U.O. Oculistica Azienda Ospedaliero-Universitaria Renato Dulbecco
      • Contact: Vincenzo Scorcia; Phone Number: +390961/883046; Email: vscorcia@unicz.it
      • Principal Investigator: Vincenzo Scorcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
• Patients (male and female) 18 years of age or older with moderate to severe dry eye syndrome or with dry eye syndrome, even after eye surgery (e.g. refractive surgery or cataract);

• Moderate to severe dry eye syndrome in one or both eyes in the presence of:

  1. Dry Eye Symptom Assessment Questionnaire (SANDE) > 60;
  2. Tear Film Break-Up Time (TFBUT) < 7 seconds. TFBUT value will be recorded as an average of 3 measurements;
  3. Test di Schirmer < 10 mm;
• Diagnosis of dry eye syndrome for at least 6 months (use or recommendation of use of artificial tears/lubricants for the treatment of dry eye);
• Patients able to understand the nature and purpose of the study, including possible risks;
• Patient able to cooperate with the Investigator and meet the requirements of the clinical investigation plan;
• Patient who, in the opinion of the Investigator, will benefit from this treatment;
• Patient available for the entire study period.

Exclusion Criteria:

• Eye infection or clinically significant inflammation in both eyes (for example: Herpes simplex infections, corneal virus infections, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye);
• History or evidence of eyelid abnormalities in either eye;
• Use of topical cyclosporine, topical corticosteroids, or any other topical medication for the treatment of ocular pathologies in either eye within 7 days of study enrollment;
• Patients being treated with chronic systemic therapies with analgesic, anti-inflammatory, corticosteroids, or opioids;
• History of ocular surgery (including laser procedures or refractive surgery) in either eye 7 days prior to enrollment;
• History or evidence of severe or uncontrolled systemic or autoimmune disease does not allow participation in the study or could impair the results;
• Patients being treated with drugs and/or medical devices and/or supplements for neuropathic pain (e.g., SNRIs (duloxetine, venlafaxine), pregabalin, gabapentin, TCAs (nortriptyline, amitriptyline));
• Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
• Participation in another clinical trial within 30 days prior to the screening visit;
• History of administration or abuse of drugs, medications, or alcohol;

• Women of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) will be excluded from participation in the study if they meet any of the following conditions:

  1. are currently pregnant or,
  2. have a positive urine pregnancy test result at visit 1,
  3. intend to become pregnant during the study treatment period or,
  4. are breastfeeding or, unwilling to resort to highly effective birth control measures, such as: hormonal contraceptives oral, implanted, transdermal or injected and/or mechanical barrier methods spermicidal concurrently with a barrier such as a condom or diaphragm or IUD during the entire course of the study and 30 days after the end of the treatment period;
• Subject unable to follow clinical investigation procedures and follow-up visits;
• Any other medical condition which, in the opinion of the Investigator, could influence participation in the clinical investigation or compromise its results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FBV_01; Ancillary medicinal substance and hyaluronic acid 0.3%	Device: FBV_01; Instill one drop into the conjunctival fornix four times a day.
Active Comparator: HYLO-VISION® SafeDrop® Gel; Hyaluronic acid 0.3%	Device: HYLO-VISION® SafeDrop® Gel; Instill one drop into the conjunctival fornix four times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of SANDE (Symptom Assessment in Dry Eye) questionnaire	Change in intensity and frequency of dry eye symptoms assessed by administration of the SANDE (Symptom Assessment in Dry Eye) questionnaire scale (0-100 visual scale). Higher scores mean worse outcome.	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of BODI (Brief Ocular Discomfort Inventory) questionnaire	Assessment of uncomfortable sensation , if present, related to eye drop instillation [tolerability] by administration of the BODI (Brief Ocular Discomfort Inventory) questionnaire, score ranging from 0 to 10. Higher scores mean worse outcome.	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Assessment of Oxford scale	"Assessment of the severity of keratoconjunctivitis by quantifying corneal and conjunctival staining (fluorescein vital staining) using the Oxford grading scale, ranging from 0 to 5. Higher scores indicate more severe surface damage.	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Assessment of TFBUT test (time of tear film rupture with fluorescein)	Evaluation of the stability of the tear film and its ability to remain intact on the ocular surface by TFBUT test (time of tear film rupture with fluorescein), expires from 0 to 20 seconds, higher values indicate improvement of the condition.	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1).
Assessment of NEIVFQ25 (National Eye Institute Visual Function Questionnaire - 25 items)	Measurement of patient-perceived visual function and the impact of eye conditions on daily activities through NEIVFQ25 (National Eye Institute Visual Function Questionnaire - 25 items) . Individual item scores are converted into a composite score ranging from 0 to 100. Higher scores indicate an improvement in the condition	V1 (Baseline), V3 (within 30±4 days after V1)
Assessment of IOP (intraocular pressure)	Measurement of intraocular pressure (IOP), typically ranging from 10 to 30 mmHg. Lower values indicate an improvement in the condition	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Slit-lamp examination (LES)	Slit-lamp examination (LES) to evaluate anterior segment structures, including the eyelids, conjunctiva, cornea, anterior chamber, iris, and lens. This is a qualitative descriptive assessment, classified as 'normal' or 'abnormal'.	V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Verification of correct medical device use by comparing the number of doses applied with the number of doses expected to be used during the treatment period	Recording the number of doses applied and the number of missed doses per day during the treatment period [compliance].	V3 (within 30±4 days after V1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation IGAS (Investigator Global Assessment of Safety)	Evaluation of investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. Lower values indicate a better result	V3 (within 30±4 days after V1)
Evaluation of records documented in the patient diary	Evaluation of patient adherence to the medical device during the study through review of the patient diary [compliance].	From V1 (Baseline) to V3 (within 30±4 days after V1)
Verification of Used and Unused Bottles Through Traceability Labels	Counting the number of bottles used, and empty/unused for the patient confirmed by the number of traceability labels detached and kept by the Investigator [compliance].	V3 (within 30±4 days after V1 (Baseline))
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Evaluation of reported adverse effects/incidents [safety]	From V1 (Baseline) to V3 (within 30±4 days after V1)

Collaborators and Investigators

• Sponsor: FB Vision S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: dry eye disease; moderate to severe dry eye syndrome
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: FBV_01/03/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No