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

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

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]).

The clinical investigation is designed as a prospective, multicentric and open-label study aimed at evaluating both the performance and the safety of IRIDIUM GARZE when used as an adjuvant treatment in patients suffering from blepharitis or blepharoconjunctivitis. It is a pre-market study that will involve approximately five investigational sites across Italy and will include a total of eighty adult participants previously diagnosed with these ocular inflammatory conditions. Recruitment will occur competitively among sites, and each patient will participate for approximately thirty days.

The central purpose of the investigation is to determine whether the addition of IRIDIUM GARZE to standard therapy leads to a measurable improvement in patients' ocular discomfort. This improvement is quantified through a change in the Global Discomfort Score (GDS), which patients evaluate on a numeric rating scale ranging from zero (absence of discomfort) to ten (maximum imaginable discomfort). The change is assessed between the baseline visit and the final visit on Day 28. Patients whose discomfort decreases by at least thirty percent from baseline are considered responders. Alongside this main outcome, the investigation also observes how individual ocular symptoms evolve during treatment, including itching, burning or stinging, morning eyelid stickiness, blurred vision fluctuations, sensitivity to light and foreign-body sensations. Changes in clinical signs such as eyelid margin hyperaemia, the presence and quantity of cylindrical dandruffs, tear film stability, corneal and conjunctival integrity and general anterior eye surface condition are also examined through standardized clinical evaluations. Participants eligible for the investigation must be adults aged eighteen or older who present with a clinical diagnosis of blepharitis or blepharoconjunctivitis in at least one eye. They must report a baseline ocular discomfort score of at least four and exhibit eyelid margin hyperaemia of at least grade one, together with the presence of at least three cylindrical dandruffs at the base of eyelashes. A tear film break-up time of ten seconds or less is required in the target eye. Subjects must also be able to understand the nature of the study, comply with its procedures, and provide written informed consent. Women of childbearing potential undergo a pregnancy test and must use reliable contraception during the study. Individuals are excluded if they have systemic or ocular disorders that could interfere with the study evaluations, if they have allergies to the components of IRIDIUM GARZE, if they are involved in other clinical investigations or if they present other conditions that the investigator deems incompatible with safe participation. IRIDIUM GARZE itself is a sterile, single-use Class IIa medical device formulated for periocular hygiene. Each gauze is impregnated with a preservative-free solution containing sodium hyaluronate FHA at 0.2%, dexpanthenol at 0.5% and carboxymethyl beta-glucan at 0.1%, combined with a natural cotton wipe. These components provide moisturising, soothing and protective properties that help soften and remove crusts, secretions or deposits associated with inflammatory or infectious ocular conditions. Patients are instructed to apply the device four times daily for twenty-eight days. If both eyes are affected, both are treated. The first application is performed at the investigational site to ensure correct technique, after which the patient continues the applications independently at home following the device's illustrated instructions.

Throughout the study, the patient attends three on-site visits. During the baseline visit, the investigator obtains informed consent, confirms eligibility and assesses ocular signs and symptoms in both eyes. Slit-lamp examinations, photographic documentation, tear film measurements, and corneal and conjunctival staining are performed. Patients receive their investigational device kit and a diary in which they record each application. On Day 14, the patient returns for an intermediate evaluation, which must occur within two hours of the most recent application to ensure that the assessments reflect short-term treatment effects. Symptom scores are collected again and the target eye undergoes the same detailed evaluations as at baseline. The investigator also reviews compliance by checking returned gauze sachets and the patient's diary. Both patients and physicians provide a qualitative judgment on treatment effectiveness and tolerability.

The final visit on Day 28 mirrors the procedure conducted on Day 14 and serves as the principal time point for assessing treatment outcomes. If a patient discontinues participation prematurely, an early termination visit is performed to capture all final assessments.

Safety monitoring is continuous from the moment informed consent is signed. Any adverse events, whether related or unrelated to the investigational device, are documented carefully until at least one month after the patient concludes the investigation. Serious adverse events must be reported to the sponsor within twenty-four hours. The protocol provides precise definitions for adverse events, adverse device effects, serious device effects, device deficiencies and treatment-emergent adverse events, ensuring consistent evaluation across sites. Risks primarily involve local reactions such as transient burning or redness, or hypersensitivity to the device components, although preclinical evidence and device characteristics suggest a favourable safety profile.

The statistical analysis focuses on detecting meaningful improvements in ocular discomfort and associated signs after twenty-eight days of treatment. The study anticipates that the combination of standard therapy with IRIDIUM GARZE will yield a higher proportion of responders compared with what is expected from standard therapy alone. Data from all eligible and evaluable patients who receive at least one application and present post-baseline measurements are included in the performance analysis set, while safety analysis encompasses all patients exposed to the device. An interim analysis will occur once forty patients complete the study, although results will not influence sample size or modify endpoints.

The study adheres strictly to ISO 14155, Good Clinical Practice and the ethical principles of the Declaration of Helsinki. All procedures are reviewed and approved by an Independent Ethics Committee before enrollment begins. Confidentiality of patient data is rigorously ensured and the sponsor provides insurance coverage in accordance with legal requirements. Once the investigation concludes, a comprehensive Clinical Investigation Report will be produced and the results will be registered in a public clinical investigation database, aligned with international transparency standards.

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.