Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye Discomfort

Multicentric Clinical Investigation on the Use of Single-dose Ophthalmic Solution Based on Hyaluronate Sodium Phosphate in the Treatment of Eye Discomfort in Particular in Case of Ocular Dryness

The purpose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.

Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.

Inclusion Criteria:

1. Subjects (male or female) must be ≥ 18 years of age;

2. Subject able to provide Informed Consent, in compliance with the good clinical practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects);

3. Subjects with ocular discomfort resulting from mild to moderate dry eye in one or both eyes determined by:

   • Scoring of ocular surface staining with fluorescein using the National Eye Institute (NEI) scale. Total score per single eye range 6-33 summing the score of cornea and conjunctiva. (Considering a normal score of 0-33);
   • Tear film break-up time with fluorescein (TFBUT) ≤ 10 seconds; The TFBUT value will be recorded as the average of 3 measurements;
   • Symptom Assessment in Dry Eye (SANDE) questionnaire ≥ 35.

4. Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator;

5. Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication;

6. Subject who in physician's opinion will benefit from this treatment.

Exclusion Criteria:

1. Corneal injuries or abrasions of traumatic origin in the eye of study;
2. Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye);
3. Sjögren's syndrome;
4. Stevens-Johnson syndrome;
5. Systemic lupus erythematosus;
6. Pathologies associated with corneal thinning;
7. Taking drugs that may interfere with tear gland secretion (beta -blockers);
8. Patients using any topical therapies such as non-steroidal antiinflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) the eye of study;
9. Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study;
10. Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device.
11. Participation in another clinical trial within the previous 30 days;
12. Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results.