Dry Eye SyndromesNCT07412860
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
A study testing FBV_01 and HYLO-VISION® SafeDrop® Gel in people with Dry Eye Syndromes and Dry Eye Disease (DED), run by FB Vision S.p.A at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye Disease (DED)
- What is being tested?
- FBV_01 and HYLO-VISION® SafeDrop® Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Mar 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
S.C. di Oculistica Azienda Ospedaliero-Universitaria di Cagliari Presidio San Giovanni di Dio
Cagliari, CA, 09124
Giuseppe Giannaccare, +39070 51092148, giuseppe.giannaccare@unica.it
Giuseppe Giannaccare
- Recruiting
U.O. Oculistica Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, CZ, 88100
Vincenzo Scorcia, +390961/883046, vscorcia@unicz.it
Vincenzo Scorcia
About this study
Official title: 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:
Read more
- 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)
- Being tested
- FBV_01, HYLO-VISION® SafeDrop® Gel
- Keywords
- moderate to severe dry eye syndrome, dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBV_01Device
Instill one drop into the conjunctival fornix four times a day.
HYLO-VISION® SafeDrop® GelDevice
Instill one drop into the conjunctival fornix four times a day.
| Study group | Role | What they receive |
|---|---|---|
| FBV_01 | Experimental | Ancillary medicinal substance and hyaluronic acid 0.3% Receives: Device: FBV_01 |
| HYLO-VISION® SafeDrop® Gel | Active comparator | Hyaluronic acid 0.3% Receives: Device: HYLO-VISION® SafeDrop® Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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'.
Measured: 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].
Measured: V3 (within 30±4 days after V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FB Vision S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412860
- Sponsor's protocol ID
- FBV_01/03/2024
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07412860
- Acronym / sponsor ID
- FBV_01/03/2024
- Conditions
- Dry Eye Syndromes, Dry Eye Disease (DED)
- Keywords
- moderate to severe dry eye syndrome, dry eye disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- FB Vision S.p.AIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FBV_01 | Experimental | Device: FBV_01Ancillary medicinal substance and hyaluronic acid 0.3% |
| HYLO-VISION® SafeDrop® Gel | Active comparator | Device: HYLO-VISION® SafeDrop® GelHyaluronic acid 0.3% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FBV_01Instill one drop into the conjunctival fornix four times a day. | Device | FBV_01 |
| HYLO-VISION® SafeDrop® GelInstill one drop into the conjunctival fornix four times a day. | Device | HYLO-VISION® SafeDrop® Gel |
Primary outcome
Assessment of SANDE (Symptom Assessment in Dry Eye) questionnaire
Time frame: V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
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.
7 secondary outcomes
Assessment of BODI (Brief Ocular Discomfort Inventory) questionnaire
Time frame: V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Assessment of Oxford scale
Time frame: 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)
Time frame: 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)
Time frame: V1 (Baseline), V3 (within 30±4 days after V1)
Assessment of IOP (intraocular pressure)
Time frame: V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)
Slit-lamp examination (LES)
Time frame: 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
Time frame: V3 (within 30±4 days after V1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBV_01 and HYLO-VISION® SafeDrop® Gel in people with Dry Eye Syndromes and Dry Eye Disease (DED), run by FB Vision S.p.A at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Ipavec (+39 340 3518447, vipavec@fb-vision.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of SANDE (Symptom Assessment in Dry Eye) questionnaire (time frame: V1 (Baseline), V2 (within 15±2 days after V1), V3 (within 30±4 days after V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.