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 consent form;
3. Are able to comprehend the full nature and the purpose of the investigation, includingpossible risks and side effects, and subjects able to cooperate with the Investigatorand to comply with the requirements of the entire investigation (including ability toattend all the planned investigation visits according to the time limits), based onInvestigator's judgement;
4. Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucoma willbe based on: optic disc assessment, measurement of the retinal nerve fiber layer andneuroretinal rim with optical coherence tomography (OCT); characteristic repeatablevisual 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 OHTwill be based on history of IOP (intraocular pressure) > 21 mmHg in at least twooccasions and normal optic disc and Humphrey visual field test;
5. Are receiving an ongoing topical therapy with two or more preserved ocular hypotensiveagents (e.g. beta-blockers, alpha-agonists, carbonic anydhrase inhibitors,prostaglandins) for at least 6 months and are willing to continue these treatments atunchanged dose for the entire investigation duration;
6. Have a diagnosis of moderate to severe DES performed through the following exams: slitlamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test, Tear FilmBreak-Up Time (TFBUT), fluorescein staining of the cornea and conjunctiva (OxfordStaining Scheme). Please note that a diagnosis of DES may be performed at entry in theinvestigation;
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 available thetest will be performed during the screening visit;
9. In case of females of child-bearing potential (i.e., not permanently sterilized - posthysterectomy or tubal ligation status - or not postmenopausal), they must have anegative 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); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion;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 investigation orknown 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 the presentinvestigation 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 planning tobecome pregnant during the investigation