This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in decreasing the number of days where adenoviral conjunctivis is detected in the eye and in reducing the duration and/or the severity of the signs and symptoms of adenoviral conjunctivis
A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing carrageenan eye drops (NCX 4240) versus placebo up to 21 days. Total expected number of patients: 148 Randomization: patients will be randomized 1:1 between: * Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8 times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days until Day 21 or * Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye 8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day 21.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
One drop in each eye 8 times per day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until Day 21
1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21
Hospital Clinico San Carlos
Madrid, Spain
Viral eradication time NCX 4240 versus Placebo
Comparison in time to viral eradication in NCX-4240 and the placebo groups (when virus load is 0 or BLD - below the limit of detection) from the tears as measured by Polymerase Chain Reaction (PCR) at each visit.
Time frame: 21 days
Quantitative PCR
1\) Quantitative PCR (qPCR) results at all clinical investigation timepoints 4) Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary 5) Ocular signs as assessed by the investigators at each visit and for both eyes
Time frame: 21 days
Impact on daily activities
Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe) 5) Ocular signs as assessed by the investigators at each visit and for both eyes: * Degree of bulbar conjunctival injection/hyperaemia will be graded using the Mc Monnies grading scale for conjunctival hyperaemia * Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis. Presence/absence of loco-regional lymphadenopathies will also be recorded
Time frame: 21 days
Patient discomfort
Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
Time frame: 21 days
bulbar conjuntival infection
Ocular signs as assessed by the investigators at each visit and for both eyes: degree of bulbar conjunctival infection/hyperaemia will be graded using the McMonnies grading scale for conjunctival hypereaemia.
Time frame: 21 days
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Other signs to be assessed
Ocular signs as assessed by the investigators at each visit and for both eyes: \- Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis.
Time frame: 21 days
loco-regional lymphadenopathies
Ocular signs as assessed by the investigators at each visit and for both eyes: Presence/absence of loco-regional lymphadenopathies
Time frame: 21 days
Ocular symptoms assessed by patients
Ocular symptoms as assessed by the patients in the patient diary: self-rated daily for 21 days: symptoms sum-score of pain, foreign body sensation, itchy eye(s), photophobia/light sensitivity, ocular secretions and eyelash matting. Assessments will be performed with Likert 5 points scales (none - traces - mild - moderate - severe).
Time frame: 21 days
Disease impact on daily activities
Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)
Time frame: 21 days
Global patient discomfort
Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
Time frame: 21 days
Adenoplus test results
AdenoPlus® test results, testing the studied eye at each post baseline visits.
Time frame: 21 days
Investigator's assessment of Membranes and pseudomembranes development
For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)
Time frame: 21 days
Investigator's assessment of Membranes and pseudomembranes development
For both eyes: timing of occurrence if any
Time frame: 21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development
For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator
Time frame: 21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development
For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination
Time frame: 21 days
Assessment of Incidence and severity of fellow eye signs and symptoms
If only one eye is affected (signs and symptoms) at baseline, assessment of the incidence and severity of the other eye signs and symptoms by the investigator
Time frame: 21 days
BCVA
Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).
Time frame: 21 days
Global assessment of patient's satisfaction
Global assessment of the patient's satisfaction with the eye drops use with a 4 points Likert scale: poor, fair, good, excellent, will be performed at Day 7, 14 and 21
Time frame: 21 days
Adverse events
Safety parameters (Adverse Events/Serious Adverse Events)
Time frame: 21 days