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

NCT06190028 | Terminated

• 1 other identifier: IS06-21-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. The underlying assumption is that ophthalmic solutions as adjuvants for the management of IOP- or glaucoma-associated dry eye may induce a protection of the eye surface with consequent improvement of the symptoms and of the overall quality of life.

Conditions

Dry Eye Syndrome; Glaucoma and Concomitant Dry Eye Syndrome; Ocular Hypertension and Concomitant Dry Eye Syndrome; Multiple Long-term Topical Hypotensive Therapy

Outcome Measures

Primary Outcomes (2)

• Efficacy Assessment of dry eye symptoms from baseline

  Changes from baseline (T0) to Day 30 (T1) of the Impact of Dry Eye on Everyday Living (IDEEL) questionnaire ("Dry Eye Symptom-Bother" module) score following treatment with IRIDIUM® A gel. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0).

  Day 30

• Efficacy Assessment of vision-related function from baseline

  Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0)

  Day 30

Secondary Outcomes (9)

• Efficacy Assessment of dry eye symptoms from baseline

  Day 60

• Efficacy assement of tear film stability

  Day 30 and Day 60

• Changes on Intraocular pressure from baseline

  Day 30 and Day 60

• Assessment of patients' production of aqueous tears from baseline

  Day 30 and Day 60

• Assessment of ocular surface health from baseline

  Day 30 and Day 60

Study Arms (1)

IRIDIUM A gel

EXPERIMENTAL

Patients will receive IRIDIUM® A gel (four boxes to be used and one spare box) and they will be instructed to bilaterally apply 1 drop per eye onto the conjunctival sac 2 times a day for 60 days (one application during the day and one before going to sleep).

Device: Iridium A Gel

Interventions

Iridium A Gel DEVICE

IRIDIUM® A gel is a sterile, preservative free ophthalmic gel, containing Carbopol, amino acids, Echinacea and Aloe extract. IRIDIUM® A gel is indicated for the protection of the eye surface particularly at night, even in the presence of changes in histological continuity and blepharitic conditions, including those of an iatrogenic nature, following the use of hypotonic eye drops and of the preservatives contained therein.

Also known as: Carbopol 0.2%

IRIDIUM A gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an age ≥ 18 years,;
• Have undergone the informed consent process and have signed an approved consent form;
• 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 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 judgement;
• Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucoma will be based on: optic disc assessment, measurement of the retinal nerve fiber layer and neuroretinal rim with optical coherence tomography (OCT); characteristic repeatable 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 in at least two occasions and normal optic disc and Humphrey visual field test;
• Are receiving an ongoing topical therapy with two or more preserved ocular hypotensive agents (e.g. beta-blockers, alpha-agonists, carbonic anydhrase inhibitors, prostaglandins) for at least 6 months and are willing to continue these treatments at unchanged dose for the entire investigation duration;
• Have a diagnosis of moderate to severe DES performed through the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test, Tear Film Break-Up Time (TFBUT), fluorescein staining of the cornea and conjunctiva (Oxford Staining Scheme). Please note that a diagnosis of DES may be performed at entry in the investigation;
• Have a Tear Film Break-Up Time (TFBUT) value \< 7 sec;
• Have performed a Humphrey Visual Field Test in the last 4 months, if not available the test will be performed during the screening visit;
• In case of females of child-bearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal), they must have a negative urine pregnancy test at T0 and use a reliable form of contraception for a least 1 month prior to T0 and throughout the investigation, according to the definition of Note 3 ofICH M3 Guideline\*.
• 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.

You may not qualify if:

• Best corrected visual acuity score \< 20/40;
• Ischemic oculopathy;
• Contraindications to use of topical solution components used in this investigation or known allergy/hypersensitivity to any of the IRIDIUM®A gel ingredients;
• Current use/use in the past 15 days of any ocular medications other than hypotensive eye drops;
• Systemic treatments known to affect tear secretion;
• Treatment with any other therapy that, according to Investigator's judgment, could interfere with the assessment of the efficacy or incidence of adverse events;
• Any history or slit lamp evidence of eye surface diseases different from DES;
• History of ocular trauma or surgery in the past 12 months;
• History of cataract in the past 6 months;
• Any history of corneal refractive surgery;
• Use of systemic steroids or immunosuppressants;
• Participation in another clinical study/investigation at the same time as the present investigation or within 30 days;
• History of drug, medication or alcohol abuse or addiction;
• Pregnant (positive urine pregnancy test) or breastfeeding women, or women planning to become pregnant during the investigation

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (3)

Policlinico San Martino

Genova, Genova, 16132, Italy

Location

AOU Pisana Ospedale Cesanello

Pisa, Pisa, 56124, Italy

Location

IRCCS Fondazione G.B. Bietti

Roma, Roma, 00183, Italy

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michele Iester, MD

  Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: June 14, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)