Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease

Inclusion Criteria:

1. Patients having signed written informed consent to participate in the study obtainedaccording to Good Clinical Practice (GCP);

2. Patients having an age ≥ 18 years;

3. Patients with a diagnosis of moderate or severe dry eye disease (according to TFOSDEWS II definition) with asthenopia and accommodative effort, assessed through thefollowing exams: visual acuity, intraocular pressure, slit lamp examination,Schirmer's test, TBUT, corneal and conjunctival staining (Oxford Staining Scheme),CVS-Q and SPEED questionnaires or previous diagnosis of dry eye disease not treatedin the previous 15 days;

4. Schirmer's test ≤ 10 mm;

5. TBUT ≤ 10 sec;

6. Fluorescein staining of the cornea and conjunctiva (Oxford scale value ≤ 2); In caseof bilateral dry eye syndrome, only the worst eye, defined as the eye with thehigher severity of impairment according to the Investigator's judgment based on theabove exams, will be considered for assessments (although both eyes will betreated). In the case of bilateral dry eye syndrome with both eyes having the samelevel of impairment, the right eye will be considered for assessments by convention.

7. Use of video terminal display more than 4 hours daily, at least five days per week (minimum twenty hours a week);

8. Patients being able to comprehend the full nature and the purpose of theinvestigation, including possible risks and side effects, and subjects able tocooperate with the Investigator and to comply with the requirements of the entireinvestigation (including ability to attend all the planned study visits according tothe time limits), based on Investigator's judgment;

9. Patients agree to not apply during the study any other eye drops product that couldinterfere (particularly, corticosteroid and antibiotics eye drops) with theinvestigational product. Use of contact lenses during then study is permitted, butthey are to be removed in the 24 hours preceding each visit and prior each MERAMIRT®application;

10. Female patients having a negative urine pregnancy test result at screening and usingan appropriate method of contraception for at least 30 days before inclusion andduring the whole investigation period, according to the definition of Note 3 of ICHM3 Guideline*, if females of childbearing potential (i.e., not permanentlysterilized - post hysterectomy or tubal ligation status - or not postmenopausal):

• Note: According to the definition of Note 3 of ICH M3 Guideline a highlyeffective 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 effectivebirth control methods include: combined (estrogen and progestogen containing)hormonal contraception associated with inhibition of ovulation (oral,intravaginal, transdermal); progestogen-only hormonal contraception associatedwith inhibition of ovulation (oral, injectable, implantable); intrauterinedevice (IUD); intrauterine hormone-releasing system (IUS); bilateral tubalocclusion; vasectomised partner; sexual abstinence.

Exclusion Criteria:

1. Patients under treatment with any therapy (drug, medical device or any other eyedrops product, particularly, corticosteroid and antibiotics eye drops) that couldinterfere with the assessment of the efficacy or incidence of adverse events;

2. Patients with presence or history of any systemic or ocular disorder, condition ordisease (with particular attention to malignancies and neuro-oncological diseases)that, according to Investigator's judgment, can interfere with the conduct of therequired investigation procedures or the assessment of the efficacy or theinterpretation of the investigation results or the incidence of adverse events;

3. Patients suffering from diseases or conditions that could interfere with theassessment of the efficacy or incidence of adverse events, such as uncorrectedpresbyopia, myopia astigmatism, hyperopia;

4. Patients with hypersensitivity and/or allergy to any of the MERAMIRT® ingredients;

5. Patients not giving their written informed consent;

6. Patients not being able to apply during the study any eye drops product;

7. Patients participating to another clinical study/investigation at the same time asthe present investigation or within 30 days;

8. Patients who have history of drug, medication or alcohol abuse or addiction.