Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07412860

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

Led by FB Vision S.p.A · Updated on 2026-02-17

74

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent
  • Male or female patients aged 18 years or older with moderate to severe dry eye syndrome or dry eye syndrome after eye surgery
  • Moderate to severe dry eye syndrome in one or both eyes with:
    1. Dry Eye Symptom Assessment Questionnaire (SANDE) score greater than 60
    2. Tear Film Break-Up Time (TFBUT) less than 7 seconds (average of 3 measurements)
    3. Schirmer test less than 10 mm
  • Diagnosis of dry eye syndrome for at least 6 months with use or recommendation of artificial tears or lubricants
  • Able to understand the study purpose and risks
  • Able to cooperate with the investigator and meet study requirements
  • Investigator believes patient will benefit from treatment
  • Available for the entire study period
Not Eligible

You will not qualify if you...

  • Eye infection or significant inflammation in both eyes (e.g., herpes simplex, bacterial, viral, or fungal conjunctivitis, tuberculosis, mycosis, purulent or herpetic blepharitis, stye)
  • History or evidence of eyelid abnormalities in either eye
  • Use of topical cyclosporine, corticosteroids, or other topical ocular medications within 7 days before enrollment
  • Chronic systemic use of analgesics, anti-inflammatories, corticosteroids, or opioids
  • Ocular surgery (including laser or refractive surgery) within 7 days before enrollment
  • Severe or uncontrolled systemic or autoimmune disease impacting participation or results
  • Use of drugs or devices for neuropathic pain (e.g., duloxetine, venlafaxine, pregabalin, gabapentin, nortriptyline, amitriptyline)
  • Known allergy or hypersensitivity to device components
  • Participation in another clinical trial within 30 days prior to screening
  • History of drug, medication, or alcohol abuse
  • Women of childbearing potential who are pregnant, breastfeeding, have a positive pregnancy test, intend to become pregnant during treatment, or unwilling to use effective birth control
  • Unable to follow study procedures and visits
  • Any other medical condition deemed by the investigator to impact participation or results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Cagliari, CA, Italy, 09124

Actively Recruiting

2

U.O. Oculistica Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, CZ, Italy, 88100

Actively Recruiting

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Research Team

V

Valeria Ipavec

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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