Evaluation of a preservative-free gel for managing glaucoma and dry eye symptoms

Evaluation of Performance and Safety of IRIDIUM® A Gel Preservative-free Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy: a Prospective, Multicentric, Open-label Clinical Investigation.

This study is testing a new preservative-free eye gel to see if it can help people with glaucoma and dry eyes feel better and manage their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (industry)
• Locations: 3 sites (Genova and 2 other locations)
• Trial ID: NCT06190028 on ClinicalTrials.gov

What this trial studies

This investigation aims to assess the safety and effectiveness of IRIDIUM® A gel, a preservative-free ophthalmic solution, in patients with glaucoma or ocular hypertension who also suffer from dry eye syndrome. The gel contains Carbopol and other ingredients designed to protect the ocular surface and improve symptoms associated with long-term topical hypotensive therapy. The study will evaluate how well this gel can enhance the quality of life for patients by alleviating dry eye symptoms while managing intraocular pressure.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with glaucoma or ocular hypertension and experiencing concomitant dry eye syndrome.

Not a fit: Patients without a diagnosis of glaucoma or ocular hypertension, or those not experiencing dry eye syndrome, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from both glaucoma and dry eye syndrome.

How similar studies have performed: Other studies have shown promise with similar preservative-free ophthalmic solutions, suggesting a potential for success in this approach.

Eligibility criteria

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, 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;
4. 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;
5. 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;
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, 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;
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 the 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 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.

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 or 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 hypotensive eye drops;
5. Systemic treatments known to affect tear secretion;
6. Treatment with any other therapy that, according to Investigator's judgment, could interfere 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 present 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 planning to become pregnant during the investigation

Where this trial is running

Genova and 2 other locations

• Policlinico San Martino — Genova, Italy (RECRUITING)
• AOU Pisana Ospedale Cesanello — Pisa, Italy (RECRUITING)
• IRCCS Fondazione G.B. Bietti — Roma, Italy (RECRUITING)

Study contacts

• Principal investigator: Michele Iester, MD — Ospedale Policlinico San Martino
• Study coordinator: Nicola Giordan

Conditions: Dry Eye Syndrome, Glaucoma and Concomitant Dry Eye Syndrome, Ocular Hypertension and Concomitant Dry Eye Syndrome, Multiple Long-term Topical Hypotensive Therapy