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).
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);
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;
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;
Parallel
FBV_01
DeviceInstill one drop into the conjunctival fornix four times a day.
HYLO-VISION® SafeDrop® Gel
DeviceInstill one drop into the conjunctival fornix four times a day.
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.
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.
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.
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.
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
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
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 \[compliance\].
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 \[compliance\].
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Evaluation of reported adverse effects/incidents \[safety\]
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