Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Management of Patients With Glaucomar or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy

Inclusion Criteria:

1. Have an age ≥ 18 years,;

2. Have undergone the informed consent process and have signed an approved consentform;

3. Are able to comprehend the full nature and the purpose of the investigation,including possible risks and side effects, and subjects able to cooperate with theInvestigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to thetime limits), based on Investigator's judgement;

4. Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucomawill be based on: optic disc assessment, measurement of the retinal nerve fiberlayer and neuroretinal rim with optical coherence tomography (OCT); characteristicrepeatable visual field defects defined as a pattern standard deviation (PSD) with P < 0.05, and/or glaucoma hemifield test (GHT) results outside normal limits.Diagnosis of OHT will be based on history of IOP (intraocular pressure) > 21 mmHg inat least two occasions and normal optic disc and Humphrey visual field test;

5. Are receiving an ongoing topical therapy with two or more preserved ocularhypotensive agents (e.g. beta-blockers, alpha-agonists, carbonic anydhraseinhibitors, prostaglandins) for at least 6 months and are willing to continue thesetreatments at unchanged dose for the entire investigation duration;

6. Have a diagnosis of moderate to severe DES performed through the following exams:slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test, TearFilm Break-Up Time (TFBUT), fluorescein staining of the cornea and conjunctiva (Oxford Staining Scheme). Please note that a diagnosis of DES may be performed atentry in the investigation;

7. Have a Tear Film Break-Up Time (TFBUT) value < 7 sec;

8. Have performed a Humphrey Visual Field Test in the last 4 months, if not availablethe test will be performed during the screening visit;

9. In case of females of child-bearing potential (i.e., not permanently sterilized -post hysterectomy or tubal ligation status - or not postmenopausal), they must havea negative urine pregnancy test at T0 and use a reliable form of contraception for aleast 1 month prior to T0 and throughout the investigation, according to thedefinition of Note 3 ofICH M3 Guideline*.

• 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. Best corrected visual acuity score < 20/40;

2. Ischemic oculopathy;

3. Contraindications to use of topical solution components used in this investigationor known allergy/hypersensitivity to any of the IRIDIUM®A gel ingredients;

4. Current use/use in the past 15 days of any ocular medications other than hypotensiveeye drops;

5. Systemic treatments known to affect tear secretion;

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. Any history or slit lamp evidence of eye surface diseases different from DES;

8. History of ocular trauma or surgery in the past 12 months;

9. History of cataract in the past 6 months;

10. Any history of corneal refractive surgery;

11. Use of systemic steroids or immunosuppressants;

12. Participation in another clinical study/investigation at the same time as thepresent investigation or within 30 days;

13. History of drug, medication or alcohol abuse or addiction;

14. Pregnant (positive urine pregnancy test) or breastfeeding women, or women planningto become pregnant during the investigation