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

NCT07412860 | Recruiting

• 1 other identifier: FBV_01/03/2024
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Dry Eye Syndromes; Dry Eye Disease (DED)

Keywords

moderate to severe dry eye syndrome; dry eye disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Assessment of BODI (Brief Ocular Discomfort Inventory) questionnaire

  V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)

• Assessment of Oxford scale

  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)

  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)

  V1 (Baseline), V3 (within 30±4 days after V1)

• Assessment of IOP (intraocular pressure)

  V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)

Other Outcomes (4)

• Evaluation IGAS (Investigator Global Assessment of Safety)

  V3 (within 30±4 days after V1)

• Evaluation of records documented in the patient diary

  From V1 (Baseline) to V3 (within 30±4 days after V1)

• Verification of Used and Unused Bottles Through Traceability Labels

  V3 (within 30±4 days after V1 (Baseline))

Study Arms (2)

FBV_01

EXPERIMENTAL

Ancillary medicinal substance and hyaluronic acid 0.3%

Device: FBV_01

HYLO-VISION® SafeDrop® Gel

ACTIVE COMPARATOR

Hyaluronic acid 0.3%

Device: HYLO-VISION® SafeDrop® Gel

Interventions

FBV_01 DEVICE

Instill one drop into the conjunctival fornix four times a day.

FBV_01

HYLO-VISION® SafeDrop® Gel DEVICE

Instill one drop into the conjunctival fornix four times a day.

HYLO-VISION® SafeDrop® Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Dry Eye Symptom Assessment Questionnaire (SANDE) \> 60;
• Tear Film Break-Up Time (TFBUT) \< 7 seconds. TFBUT value will be recorded as an average of 3 measurements;
• 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.

You may not qualify if:

• 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:
• are currently pregnant or,
• have a positive urine pregnancy test result at visit 1,
• intend to become pregnant during the study treatment period or,
• 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;

Sponsors & Collaborators

• FB Vision S.p.A: lead

Study Sites (2)

S.C. di Oculistica Azienda Ospedaliero-Universitaria di Cagliari Presidio San Giovanni di Dio

Cagliari, CA, 09124, Italy

RECRUITING

U.O. Oculistica Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, CZ, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Valeria Ipavec

CONTACT

+39 340 3518447; vipavec@fb-vision.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled partecipants will be randomly assigned in a 1:1 ratio to receive the medical device containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV\_01) or hyaluronic acid.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 17, 2026
• Study Start: March 26, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)