Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFidia Farmaceutici s.p.a.
About this trial
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 \[+2 days\]).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
IRIDIUM GARZE
DeviceRIDIUM GARZE will be used for 28 days, 4 times a day
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: IRIDIUM GARZEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in Ocular Global Discomfort
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.
Time frame
28 daysSecondary outcomes
1
Reduction of individual symptoms (itching, burning/stinging, sticky eye in the morning, fluctuating blurred vision, light sensitivity, foreign body sensation)
Changes from baseline of individual symptoms of blepharitis or blepharoconjunctivitis (itching, burning/stinging, sticky eye in the morning, fluctuating blurred vision, light sensitivity,foreign body sensation) in the target eye measured using a 0-10 NRS within two hours from the last application.
Time frame
28 days2
Improvement of the degree of eyelid margin hyperaemia
Change from baseline in eyelid margin hyperaemia in the target eye. Eyelid margin hyperaemia will be evaluated by slit-lamp examination, using photos produced by the instruments: eyelid margin hyperaemia will be graded on a scale of 0 (normal) to 4 (severe) for the upper and lower eyelids of each eye.
Time frame
28 days3
Improvement of the number of cylindrical dandruffs
Change from baseline in the number of cylindrical dandruffs in the target eye. Cylindrical dandruffs will beevaluated by slit-lamp examination, using photos produced by theinstruments and cylindrical dandruffs will be counted at the inferior andsuperior base of the eyelashes.
Time frame
28 days4
Normalization of the tear film
Change from baseline of Tear Film Break-Up Time (TBUT) in the target eye.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov