Clinical Research Directory

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

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 \[+2 days\]).