Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07431385
NA

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

Sponsor: Fidia Farmaceutici s.p.a.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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