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Study stopped following management decision
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| Name | Class |
|---|---|
| Iris Pharma | INDUSTRY |
| Theradis pharma | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye drops containing Iota-Carrageenan | Active Comparator | Eye drops 3.2mg/ml |
|
| Ocular Lubricant Eye Drops | Placebo Comparator | Carmellose 0.5% sterile solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iota-Carrageenan | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Duquesroix | NicOx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D002351 | Carrageenan |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
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|
| Carmellose | Drug | 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 |
|
|
| 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:
|
| 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 | 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. | 21 days |
| 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. | 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 | 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). | 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) | 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 | 21 days |
| Adenoplus test results | AdenoPlus® test results, testing the studied eye at each post baseline visits. | 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) | 21 days |
| Investigator's assessment of Membranes and pseudomembranes development | For both eyes: timing of occurrence if any | 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 | 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 | 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 | 21 days |
| BCVA | Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21). | 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 | 21 days |
| Adverse events | Safety parameters (Adverse Events/Serious Adverse Events) | 21 days |
| D005936 |
| Glucans |