Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)

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.

• Iota-Carrageenan (Drug), also known as NCX-4240: 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
• Carmellose (Drug), also known as Placebo: 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

Primary outcomes

• Viral eradication time NCX 4240 versus Placebo [21 days]: 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.

Secondary outcomes

• Quantitative PCR [21 days]: 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
• Impact on daily activities [21 days]: 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
• Patient discomfort [21 days]: Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
• bulbar conjuntival infection [21 days]: 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.
• Other signs to be assessed [21 days]: 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.
• loco-regional lymphadenopathies [21 days]: Ocular signs as assessed by the investigators at each visit and for both eyes: Presence/absence of loco-regional lymphadenopathies
• Ocular symptoms assessed by patients [21 days]: 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).
• Disease impact on daily activities [21 days]: Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)
• Global patient discomfort [21 days]: Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
• Adenoplus test results [21 days]: AdenoPlus® test results, testing the studied eye at each post baseline visits.
• Investigator's assessment of Membranes and pseudomembranes development [21 days]: For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)
• Investigator's assessment of Membranes and pseudomembranes development [21 days]: For both eyes: timing of occurrence if any
• Investigator's assessment of Subepithelial Corneal Infiltrates development [21 days]: For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator
• Investigator's assessment of Subepithelial Corneal Infiltrates development [21 days]: For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination
• Assessment of Incidence and severity of fellow eye signs and symptoms [21 days]: 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
• BCVA [21 days]: Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).
• Global assessment of patient's satisfaction [21 days]: 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
• Adverse events [21 days]: Safety parameters (Adverse Events/Serious Adverse Events)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test
* Conjunctivis signs and symptoms in at least one eye AND positive adenoplus test in at least one eye whatever signs/symptoms and positive adenoplus test are from the same eye or not

Exclusion Criteria:

* Negative results with adenoplus test in both eyes
* a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation

• Brigitte Duquesroix, Study director, NicOx