IRIDIUM GARZE to reduce symptoms of blepharitis and blepharoconjunctivitis

A Prospective, Multicentric, Open-label Clinical Investigation to Evaluate the Performance and Safety of the Use of IRIDIUM GARZE as Adjuvant Treatment in Patients With Blepharitis or Blepharoconjunctivitis

This will try IRIDIUM GARZE as an added treatment to see if it reduces eye discomfort in adults with blepharitis or blepharoconjunctivitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Locations: 5 sites (Bari and 4 other locations)
• Trial ID: NCT07431385 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label investigation enrolling about 80 adults at roughly five Italian ophthalmology sites who will receive standard therapy plus IRIDIUM GARZE applied four times daily for 28 days. The primary outcome is change in the patient-reported Global Discomfort Score (GDS) from baseline to Day 28, with responders defined as a ≥30% reduction. Secondary measures include detailed symptom and sign changes, investigator and patient evaluations, and safety monitoring. Patients are screened by slit-lamp exam with minimum symptom and clinical sign thresholds required for enrollment.

Who should consider this trial

Good fit: Adults (≥18) with a clinical diagnosis of blepharitis or blepharoconjunctivitis, baseline GDS ≥4, eyelid margin hyperaemia and at least three collarettes at lash bases, and tear break-up time ≤10 seconds are ideal candidates.

Not a fit: Patients with mild symptoms below the enrollment thresholds (GDS <4), alternative causes of eye symptoms, or those unable to follow the application schedule are less likely to benefit.

Why it matters

Potential benefit: If successful, adding IRIDIUM GARZE could reduce ocular discomfort and improve eyelid inflammation signs when used alongside standard therapy.

How similar studies have performed: Formulations containing hyaluronic acid and dexpanthenol have shown symptom relief for dry eye and ocular surface irritation, but adjuvant use specifically for blepharitis/blepharoconjunctivitis is less well studied.

Eligibility criteria

Inclusion Criteria:

1. Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP) and International Organization for Standardization (ISO) 14155.
2. Patients of either sex aged ≥ 18 years.
3. Patients with a diagnosis of blepharitis or blepharoconjunctivitis in at least one eye assessed through slit lamp examination.
4. Patients with Global Discomfort Score (GDS) ≥4 using the 0-10 numeric rating scale (NRS) ranging from 0 (no ocular discomfort) to 10 (worst ocular discomfort imaginable) in the target eye.
5. Patients with an eyelid margin hyperaemia score ≥1 (as graded using a 4-point scale from 0: none to 4: severe) and at least three CDs at the base of the eyelashes in the target eye.
6. TBUT ≤ 10 seconds in the target eye.
7. Patients being able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and patients 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 judgment.
8. Female patients must have a negative urine pregnancy test and use a highly effective form of contraception for at least one month prior to screening and throughout the investigation; or females must be surgically sterile, or postmenopausal as documented in medical history for at least one year. Highly effective birth control methods include combined hormonal contraception (containing oestrogen and progesterone) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormonereleasing system (IUS); bilateral tubal occlusion; vasectomised partner, sexual abstinence\*.

   * Note: According to the definition of Note 3 of ICH M3 Guideline highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. For patients using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.

Exclusion Criteria:

1. Patients under treatment with any therapy that, based on Investigator's judgment, could interfere with the assessment of the performance or incidence of adverse events. Patients using tear substitutes can be enrolled in the investigation. Same eye drops and dosage should be maintained for the entire duration of the clinical investigation.
2. Patients with presence or history of any systemic or ocular disorder, condition or disease (with particular attention to autoimmune \[including but not limited to Sjogren's syndrome and rheumatoid arthritis\], malignancies and neuro-oncological diseases, ocular trauma, ocular surgery) that, according to Investigator's judgment, can interfere with the conduction of the required investigation procedures or the assessment of the performance or the interpretation of the investigation results or the incidence of adverse events.
3. Patients with hypersensitivity and/or allergy to any of the IRIDIUM GARZE components.
4. Patients not giving their written informed consent.
5. Patients participating in another clinical study/investigation at the same time as the present investigation or within 30 days prior to screening visit.
6. Patients who have history of drug, medication or alcohol abuse or addiction.
7. Patients using contact lenses are allowed be included only if they agree to not use them for the entire duration of the investigation.

Where this trial is running

Bari and 4 other locations

• Oftalmologia Universitaria - Azienda Ospedaliera Policlinico Consorziale di Bari — Bari, Italy (Recruiting)
• Clinica Oculistica - A.O. Universitaria di Cagliari- San Giovanni di Dio — Cagliari, Italy (Recruiting)
• Clinica Oculistica - blocco B piano 5 ASST Santi Paolo e Carlo P.O. San Paolo — Milan, Italy (Recruiting)
• Oftalmologia - Fondazione Policlinico Universitario Campus Bio-Medico Roma — Roma, Italy (Recruiting)
• SC (UCO) Clinica oculistica - Azienda Sanitaria Universitaria Integrata di Trieste — Trieste, Italy (Recruiting)

Study contacts

• Study coordinator: Nicola Giordan

Conditions Blepharitis; Blepharoconjunctivitis; Hyaluronic Acid; Dexpanthenol; Ocular discomfort; Periocular Hygiene