Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment (NCT07431385) | Clinical Trial Compass
RecruitingNot Applicable
Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment
Italy80 participantsStarted 2025-09-17
Plain-language 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 \[+2 days\]).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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\*.
Exclusion criteria
. Patients under treatment with any therapy that, based on Investigator's judgment, could interfere with the assessment of the performance or incidence of adverse events. Patients using tear substitutes can be enrolled in the investigation. Same eye drops and dosage should be maintained for the entire duration of the clinical investigation.
. Patients with presence or history of any systemic or ocular disorder, condition or disease (with particular attention to autoimmune \[including but not limited to Sjogren's syndrome and rheumatoid arthritis\], malignancies and neuro-oncological diseases, ocular trauma, ocular surgery) that, according to Investigator's judgment, can interfere with the conduction of the required investigation procedures or the assessment of the performance or the interpretation of the investigation results or the incidence of adverse events.
. Patients with hypersensitivity and/or allergy to any of the IRIDIUM GARZE components.
. Patients not giving their written informed consent.
. Patients participating in another clinical study/investigation at the same time as the present investigation or within 30 days prior to screening visit.
. Patients who have history of drug, medication or alcohol abuse or addiction.
. Patients using contact lenses are allowed be included only if they agree to not use them for the entire duration of the investigation.