Actively Recruiting
Performance and Safety of IRIDIUM GARZE as Adjuvant Treatment in Adults With Blepharitis or Blepharoconjunctivitis
Led by Fidia Farmaceutici s.p.a. · Updated on 2026-02-24
80
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of IRIDIUM GARZE as an additional treatment for adults diagnosed with blepharitis or blepharoconjunctivitis. The study focuses on measuring improvement in eye discomfort using a Global Discomfort Score on a numeric scale. This open-label, multicenter clinical investigation involves about eighty adult patients across multiple sites in Italy and aims to assess both the performance and safety of IRIDIUM GARZE alongside standard therapy over 28 days. Participants receive IRIDIUM GARZE, a sterile Class IIa medical device for periocular hygiene, applied four times daily for 28 days to the affected eye(s). The device contains moisturizing and soothing components like sodium hyaluronate, dexpanthenol, and carboxymethyl beta-glucan combined with a cotton wipe. If both eyes are affected, both receive treatment. The first application is done under supervision in the clinic, followed by independent home use. The study includes three on-site visits: baseline (Day 0), mid-treatment (Day 14), and final assessment (Day 28). During the study, patients undergo detailed eye examinations, including slit-lamp evaluations, photographic documentation, tear film tests, and corneal and conjunctival staining. They record device use in a diary and return used gauze sachets for compliance checks. Researchers assess changes in ocular discomfort, symptoms like itching and burning, eyelid redness, tear film stability, and eye surface condition. Safety is monitored throughout, recording any adverse events up to one month after treatment ends. The main outcome is the change in global discomfort score from baseline to Day 28, with responders defined by a reduction of at least 30%.
CONDITIONS
Brief Title
Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent according to Good Clinical Practice and ISO 14155.
- Age 18 years or older.
- Diagnosis of blepharitis or blepharoconjunctivitis in at least one eye confirmed by slit lamp examination.
- Global Discomfort Score of 4 or higher on a 0-10 scale in the target eye.
- Eyelid margin hyperaemia score of at least 1 and at least three cylindrical dandruffs at the base of eyelashes in the target eye.
- Tear Break-Up Time of 10 seconds or less in the target eye.
- Ability to understand the study purpose and comply with study requirements.
- Female patients must have a negative pregnancy test and use effective contraception or be surgically sterile or postmenopausal for at least one year.
You will not qualify if you...
- Treatment with therapies that could interfere with study assessments, except tear substitutes maintained at the same dose.
- Presence or history of systemic or ocular disorders that may affect study procedures or results, including autoimmune diseases, malignancies, ocular trauma, or surgery.
- Hypersensitivity or allergy to any components of IRIDIUM GARZE.
- Lack of written informed consent.
- Participation in another clinical study within 30 days prior to screening.
- History of drug, medication, or alcohol abuse.
- Use of contact lenses unless agreeing not to wear them during the study period.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants apply IRIDIUM GARZE device to the affected eye(s) four times daily for 28 days as an adjuvant treatment to standard therapy.
3 visits (baseline, Day 14, Day 28)
Duration - At least 1 month after treatment
Safety monitoring and documentation of any adverse events continue from informed consent signing until at least one month after treatment ends.
Visits as needed for safety monitoring
Trial Site Locations
Total: 5 locations
1
Oftalmologia Universitaria - Azienda Ospedaliera Policlinico Consorziale di Bari
Bari, Italy, 70120
Actively Recruiting
2
Clinica Oculistica - A.O. Universitaria di Cagliari- San Giovanni di Dio
Cagliari, Italy, 09124
Actively Recruiting
3
Clinica Oculistica - blocco B piano 5 ASST Santi Paolo e Carlo P.O. San Paolo
Milan, Italy, 20142
Actively Recruiting
4
Oftalmologia - Fondazione Policlinico Universitario Campus Bio-Medico Roma
Roma, Italy, 00128
Actively Recruiting
5
SC (UCO) Clinica oculistica - Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Italy, 34128
Actively Recruiting
Research Team
N
Nicola Giordan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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