Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome

Inclusion Criteria:

1. Patient written informed consent to participate in the study obtained according toGood Clinical Practice (GCP);

2. Male and female patients aged ≥18 years;

3. Patients with new diagnosis of dry eye syndrome (according to Tear Film and OcularSurface Society [TFOS] Dry Eye Workshop [DEWS] II definition), or previous diagnosisof dry eye syndrome not treated in the previous 15 days;

4. Diagnosis of dry eye syndrome performed through the following exams: slit lampexamination (SLE), Impact of Dry Eye on Everyday Living (IDEEL) questionnaire, tear (lacrimal) meniscus exam, Schirmer's test, Tear Film Break-Up Time (TFBUT),fluorescein and lissamine green staining of the cornea and conjunctiva (respectively). In case of bilateral dry eye syndrome, only the worst eye, definedas the eye with the higher severity of impairment according to theInvestigator'sjudgment based on the above exams, will be considered for assessments (although botheyes will be treated). In the case of bilateral dry eye syndrome with both eyeshaving the same level of impairment, the right eye will be considered forassessments by convention;

5. Sodium fluorescein and lissamine green staining score of the cornea andconjunctiva(respectively) ≥ 2 National Eye Institute (NEI) grid, defined as the sumof 5 areas per eye using a 0 (normal) to 3 (severe) scale) in the worst eye for thecorneal staining and the sum of 6 areas per eye using a 0 (normal) to 3 (severe)scale in the worst eye for the conjunctival staining;

6. A Schirmer test value < 10 mm;

7. A TFBUT value ≥ 5 sec;

8. Patient able to comprehend the full nature and the purpose of the study, includingpossible risks and side effects, and subjects able to cooperate with theInvestigator and to comply with the requirements of the entire study (includingability to attend all the planned study visits according to the time limits), basedon Investigator's judgment;

9. Females of childbearing potential (i.e., not permanently sterilised - posthysterectomy or tubal ligation status - or not postmenopausal for at least one year)must have a negative urine pregnancy test result at Screening and must use anappropriate method of contraception for at least 30 days before inclusion in thestudy and during the whole study period, according to the definition in ICH M3Guideline:

A highly effective method is defined as that 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.

Exclusion Criteria:

1. Any ocular disease other than dry eye syndrome requiring treatment withophthalmological topical medications with re-epithelizing, trophic, anti-infectiveor anti-inflammatory effect (e.g. antibiotics, corticosteroids, gel re-epithelizing,platelet-rich plasma, autologous serum, medication with vitamin A, hyaluronicacid-based products) in either eye at the time of study enrolment and in theprevious 30 days;

2. Any active ocular infection or active inflammation in either eye unrelated to dryeye syndrome;

3. Presence or history of any systemic or ocular disorder, condition or disease (withparticular attention to malignancies and neuro-oncological diseases) that, accordingto Investigator's judgment, can interfere with the conduct of the required studyprocedures or the assessment of the efficacy or the interpretation of the studyresults or the incidence of adverse events;

4. Use of therapeutic or refractive contact lenses in either eye in the previous 20days and at the time of study enrolment;

5. History of ocular surgery in either eye, excluding corneal refractive or cataractprocedures, within 90 days of study enrolment;

6. Treatment with any other therapy that, according to Investigator's judgment, couldinterfere with the assessment of the efficacy or incidence of adverse events;

7. Hypersensitivity and/or allergy to any of Myrialen® gel and/or Recugel® ingredients;

8. Women pregnant or breastfeeding or women who could become pregnant and are not usingeffective contraception;

9. Patients unlikely to comply with the protocol or unable to understand the nature,scope and possible consequences of the investigation;

10. Participation in another clinical investigation within the past 30 days or previousenrolment in this investigation.