Clinical trial NCT03009799: Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
Official title: Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adenoviral Conjunctivitis
Keywords: adenoviral conjunctivis
iota-carrageenan
Lead sponsor: NicOx
Sponsor class: INDUSTRY
Collaborators: name: Iris Pharma
name: Theradis pharma
First posted: 2017-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral eradication time NCX 4240 versus Placebo
timeFrame: 21 days
Secondary outcomes:
measure: Quantitative PCR
timeFrame: 21 days
measure: Impact on daily activities
timeFrame: 21 days
measure: Patient discomfort
timeFrame: 21 days
measure: bulbar conjuntival infection
timeFrame: 21 days
measure: Other signs to be assessed
timeFrame: 21 days
measure: loco-regional lymphadenopathies
timeFrame: 21 days
measure: Ocular symptoms assessed by patients
timeFrame: 21 days
measure: Disease impact on daily activities
timeFrame: 21 days
measure: Global patient discomfort
timeFrame: 21 days
measure: Adenoplus test results
timeFrame: 21 days
measure: Investigator's assessment of Membranes and pseudomembranes development
timeFrame: 21 days
measure: Investigator's assessment of Membranes and pseudomembranes development
timeFrame: 21 days
measure: Investigator's assessment of Subepithelial Corneal Infiltrates development
timeFrame: 21 days
measure: Investigator's assessment of Subepithelial Corneal Infiltrates development
timeFrame: 21 days
measure: Assessment of Incidence and severity of fellow eye signs and symptoms
timeFrame: 21 days
measure: BCVA
timeFrame: 21 days
measure: Global assessment of patient's satisfaction
timeFrame: 21 days
measure: Adverse events
timeFrame: 21 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: NicOx
name: Brigitte Duquesroix
role: STUDY_DIRECTOR
References: