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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 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-02-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Michele Iester, MD · Ospedale Policlinico San Martino

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2025-03-10
Completion
2025-03-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190028 on ClinicalTrials.gov