Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
- Conditions
- Adenoviral Conjunctivitis
- Interventions
- Registration Number
- NCT03009799
- Lead Sponsor
- NicOx
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Negative results with adenoplus test in both eyes
- a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocular Lubricant Eye Drops Carmellose Carmellose 0.5% sterile solution Eye drops containing Iota-Carrageenan Iota-Carrageenan Eye drops 3.2mg/ml
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 recordedbulbar 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 lymphadenopathiesOcular 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
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: timing of occurrence if any
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)
Trial Locations
- Locations (1)
Hospital Clinico San Carlos
🇪🇸Madrid, Spain