Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%

Inclusion Criteria

• •Patients who meet all the following criteria at the screening/baseline visit will be considered as eligible for the investigation:
• •1. Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP);
• •2. Patients having an age ≥ 18 years;
• •3. Patients with diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \[TFOS\] Dry Eye Workshop \[DEWS\] definition);
• •4. Diagnosis of dry eye syndrome for the investigation assessed through at least the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test I, TFBUT, cornea and conjunctiva staining, IDEEL questionnaire ("Dry Eye Symptom-Bother" module); 4a) Diagnosis of mild dry eye syndrome will be based on the following criteria:
• •* TFBUT 7-10 sec
• •* Schirmer's test I 7-10 mm
• •* Fluorescein staining of the cornea and conjunctiva (NEI scale value) \<7
• •* IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score 40-50
• •* Patient not treated in the previous 15 days for dry eye syndrome 4b) Diagnosis of moderate to severe dry eye syndrome will be based on the following criteria:
• •* TFBUT \< 7 sec
• •* Schirmer's test I \< 7 mm
• •* Fluorescein staining of the cornea and conjunctiva (NEI scale value) ≥7
• •* IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score \>50
• •* Dry eye syndrome treatment permitted; no ophthalmic gel treatment permitted
• •In case of bilateral dry eye syndrome, both eyes will be treated but only the worst eye, defined as the eye with the higher severity of impairment according to the Investigator's judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention; In case of monolateral dry eye syndrome, both eyes will be treated. Evaluations of both the eyes will be collected but only target eye evaluations will be used for statistical analysis.
• •5. Patients being able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and patients able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgment;
• •6. Female patients having a negative urine pregnancy test result at screening and using an appropriate method of contraception for at least 30 days before inclusion and during the whole investigation period, according to the definition of Note 3 of ICH M3 Guideline\*, if females of childbearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal);
• •* Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.