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Tests treatment safety and results for Blepharitis
Official title Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment
ClinicalTrials.gov ID: NCT07431385
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP) and...
- 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...
- 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...
You likely can't join if
- Patients under treatment with any therapy that, based on Investigator's judgment, could interfere with the assessment of the performance or incidence...
- Patients with presence or history of any systemic or ocular disorder, condition or disease (with particular attention to autoimmune [including but...
- 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...
- Patients who have history of drug, medication or alcohol abuse or addiction.
See the full eligibility 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.
- 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...
- 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...
- 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)...
- 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...
- 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]...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bari, Italy
- Cagliari, Italy
- Milan, Italy
- Roma, Italy
- Trieste, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bari, Italy; Cagliari, Italy; Milan, Italy; Roma, Italy; Trieste, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.