Actively Recruiting
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
Led by FB Vision S.p.A · Updated on 2026-02-17
74
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an ophthalmic solution containing an ancillary medicinal substance combined with hyaluronic acid 0.3% (called FBV_01) compared to hyaluronic acid 0.3% alone in adults aged 18 years and older who have moderate-to-severe dry eye syndrome. The study aims to determine if the combination solution is at least as effective in improving dry eye symptoms and is safe, well tolerated, and used properly by participants over the treatment period. Participants will be randomly assigned to one of two groups: one using the FBV_01 solution and the other using hyaluronic acid 0.3% alone. Each participant will apply one drop in both eyes four times daily every 4 ± 1 hours for about 30 days. This is a multicenter, prospective, randomized, open-label, controlled study lasting approximately 12 months, including an enrollment period of about 11 months. During the study, participants will attend visits at baseline, within 15 ± 2 days, and within 30 ± 4 days after starting treatment for assessments of dry eye signs and symptoms, safety, tolerability, and treatment compliance. The main outcome is the Symptom Assessment in Dry Eye (SANDE) questionnaire. Additional evaluations include ocular discomfort, tear film stability, eye surface condition, visual function, intraocular pressure, slit-lamp exams, and monitoring correct use of the study devices.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Patients able to provide written informed consent
- Adults aged 18 years or older with moderate to severe dry eye syndrome or dry eye after eye surgery
- Moderate to severe dry eye in one or both eyes with SANDE questionnaire score above 60
- Tear Film Break-Up Time (TFBUT) less than 7 seconds, averaged over 3 measurements
- Schirmer test result less than 10 mm
- Dry eye syndrome diagnosed for at least 6 months, including use or recommendation of artificial tears or lubricants
- Patients able to understand the study purpose and cooperate with study procedures
- Patients considered by the investigator to potentially benefit from treatment
- Patients available for the entire study duration
You will not qualify if you...
- Eye infection or significant inflammation in both eyes (e.g., herpes simplex, bacterial or viral conjunctivitis, blepharitis, stye)
- History or presence of eyelid abnormalities in either eye
- Use of topical cyclosporine, corticosteroids, or other topical ocular medications within 7 days before enrollment
- Ongoing chronic systemic therapy with analgesics, anti-inflammatories, corticosteroids, or opioids
- Eye surgery within 7 days prior to enrollment
- Severe or uncontrolled systemic or autoimmune disease affecting participation or results
- Treatment with drugs or devices for neuropathic pain (e.g., duloxetine, pregabalin, gabapentin, nortriptyline, amitriptyline)
- Known or potential allergy or hypersensitivity to any component of the medical device
- Participation in another clinical trial within 30 days before screening
- History of drug, medication, or alcohol abuse
- Women of childbearing potential who are pregnant, breastfeeding, or unwilling to use highly effective birth control during the study and 30 days after
- Inability to follow study procedures or attend follow-up visits
- Any other medical condition that could affect participation or study results according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants receive topical administration of either FBV_01 or Hyaluronic Acid 0.3% four times a day.
3 visits (baseline, at about 15 days, and at about 30 days)
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
Research Team
V
Valeria Ipavec
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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