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 \[+2 days\]).
• 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.
• Patients of either sex aged ≥ 18 years.
• Patients with a diagnosis of blepharitis or blepharoconjunctivitis in at least one eye assessed through slit lamp examination.
• 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.
• 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.
• TBUT ≤ 10 seconds in the target eye.
• 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.
• 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.