Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment

NCT07431385 | Recruiting

• 1 other identifier: R10S-24-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

The study will evaluate the clinical improvement in ocular symptoms using IRIDIUM GARZE as adjuvant treatment in patients suffering of blepharitis or blepharoconjunctivitis as primary objective. The Change from baseline (T0) to Day 28 (T2) in overall ocular discomfort (Global Discomfort Score - GDS) using a 0-10 numeric rating scale (NRS) in the target eye. Subjects with a change from baseline to Day 28 (T2) at least equal to 30% of baseline value will be classified as responders. Also, secondary objectives will assess performance, physician evaluation, patient evaluation and safety of IRIDIUM GARZE. This multicentric, prospective, open-label clinical investigation will aim to enrol 80 adult patients in about five sites located in Italy. Patients with diagnosis of blepharitis or blepharoconjunctivitis in at least one eye will be enrolled and will receive standard therapy plus IRIDIUM GARZEfor 28 days. Patients will be instructed to use IRIDIUM GARZE 4 times a day for 28 days on the target eye. Administration will take place at regular times during the day. In case that both the target eye and the contralateral eye are affected (or the contralateral eye will become affected during the investigation), administration of the investigational device will take place in both eyes. Patients will perform 3 visits on site: initial Screening/Baseline Visit 1- T0 (Day 0); Visit 2-T1 (Day 14 \[±2 days\]) and Visit 3-T2 (Day 28 \[+2 days\]).

Conditions

Blepharitis; Blepharoconjunctivitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in Ocular Global Discomfort

  Change from baseline (T0) to Day 28 (T2) in overall ocular discomfort (Global Discomfort Score - GDS) using a 0-10 numeric rating scale (NRS) in the target eye\*. Subjects with a change from baseline to Day 28 (T2) at least equal to 30% of baseline value will be classified as responders.

  28 days

Secondary Outcomes (12)

• Reduction of individual symptoms (itching, burning/stinging, sticky eye in the morning, fluctuating blurred vision, light sensitivity, foreign body sensation)

  28 days

• Improvement of the degree of eyelid margin hyperaemia

  28 days

• Improvement of the number of cylindrical dandruffs

  28 days

• Normalization of the tear film

  28 days

• Improvement of corneal state

  28 days

Study Arms (1)

IRIDIUM GARZE

EXPERIMENTAL

IRIDIUM GARZE, a pre-marked, class IIa, non-invasive medical device, is indicated for periocular hygiene and the removal, from the eyelids and eyelashes, of crusts, eye rheums or secretions due to inflammatory and/or infectious phenomena. The main component of IRIDIUM GARZE are Sodium hyaluronate FHA (Fidia Hyaluronic Acid) 1.0 0.2%, Dexpanthenol 0.5%, Sodium carboxymethyl betaglucan 0.1% and Cotton wipe.

Device: IRIDIUM GARZE

Interventions

IRIDIUM GARZE DEVICE

RIDIUM GARZE will be used for 28 days, 4 times a day

IRIDIUM GARZE

Eligibility Criteria

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

You may qualify if:

• 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.
• Patients of either sex aged ≥ 18 years.
• Patients with a diagnosis of blepharitis or blepharoconjunctivitis in at least one eye assessed through slit lamp examination.
• 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.
• 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.
• TBUT ≤ 10 seconds in the target eye.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Patients with hypersensitivity and/or allergy to any of the IRIDIUM GARZE components.
• Patients not giving their written informed consent.
• Patients participating in another clinical study/investigation at the same time as the present investigation or within 30 days prior to screening visit.
• Patients who have history of drug, medication or alcohol abuse or addiction.
• Patients using contact lenses are allowed be included only if they agree to not use them for the entire duration of the investigation.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (5)

Oftalmologia Universitaria - Azienda Ospedaliera Policlinico Consorziale di Bari

Bari, 70120, Italy

RECRUITING

Clinica Oculistica - A.O. Universitaria di Cagliari- San Giovanni di Dio

Cagliari, 09124, Italy

RECRUITING

Clinica Oculistica - blocco B piano 5 ASST Santi Paolo e Carlo P.O. San Paolo

Milan, 20142, Italy

RECRUITING

Oftalmologia - Fondazione Policlinico Universitario Campus Bio-Medico Roma

Roma, 00128, Italy

RECRUITING

SC (UCO) Clinica oculistica - Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, 34128, Italy

RECRUITING

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Nicola Giordan

CONTACT

+390498232512; ngiordan@fidiapharma.it

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: February 16, 2026
• First Posted: February 24, 2026
• Study Start: September 17, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)