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Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment
Sponsor: Fidia Farmaceutici s.p.a.
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 \[+2 days\]).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-09-17
Completion Date
2026-06
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
IRIDIUM GARZE
RIDIUM GARZE will be used for 28 days, 4 times a day
Locations (5)
Oftalmologia Universitaria - Azienda Ospedaliera Policlinico Consorziale di Bari
Bari, Italy
Clinica Oculistica - A.O. Universitaria di Cagliari- San Giovanni di Dio
Cagliari, Italy
Clinica Oculistica - blocco B piano 5 ASST Santi Paolo e Carlo P.O. San Paolo
Milan, Italy
Oftalmologia - Fondazione Policlinico Universitario Campus Bio-Medico Roma
Roma, Italy
SC (UCO) Clinica oculistica - Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Italy