NCT06190028

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The main component of IRIDIUM® A gel is the Carbomer Carbopol 980 NF, a water-soluble polyacrylic acid with good mucoadhesion. It gives the gel the chemical-physical properties of viscosity and elasticity necessary for proper lubrication of the eyelids, forming a stable fluid film on the outer eye it provides protection to the eye surface, particularly at night. The first approach to treat patients with ocular surface diseases relies on the use of artificial tears. Tear substitutes increase the volume of fluid on the ocular surface, thus reducing cell damage. Indeed, they induce a decrease in the osmotic pressure of the tear film and of the friction caused by eyelid movements. For this, aqueous gels formulated using hydrophilic polymers along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. Among these, eye drops containing carbomers or sodium hyaluronate are increasingly being used because of their non-Newtonian time-dependent response to shear strain, resulting in a longer ocular residence time. Dry eye can also occur following specific treatments. In this regard, has been reported that dry eye symptoms are more prevalent in patients with IOP and/or glaucoma using topical IOP-lowering medications compared to the general population. The evidence from literature suggests that different topical anti-IOP/glaucoma medications have different levels of impact on the health of the ocular surface. The main driver for this observation is the presence of preservatives in topical IOP-lowering medications. Generally, preservative-free medications have fewer adverse effects compared with preserved medications. However, the presence of preservatives, such as benzalkonium chloride (BAK), in antihypertensive eye drops used for long term therapy can cause ocular discomfort symptoms in glaucoma patients. BAK reduces the stability of the tear film by acting as a detergent on the lipid layer, by reducing the number of mucin secreting goblet cells, thus altering mucin presence and distribution over the ocular surface epithelium. Clinicians need to take proactive decisions to manage ocular surface diseases of glaucoma patients as they are serious, chronic conditions. Previous findings confirm that glaucoma patients have a higher need for the use of artificial tears than age-matched controls , emphasizing that patients with ocular surface disease secondary to the chronic use of antiglaucoma medications should be preferably treated with preservative-free artificial tears.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Iridium A Gel	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.

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2024-01-05
• Last updated: 2026-02-25

Locations

3 sites across 1 country: Italy