Adenoviral Conjunctivitis
Conditions
Keywords
adenoviral conjunctivis, iota-carrageenan
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.
Interventions
DRUGIota-Carrageenan
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
DRUGCarmellose
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
Sponsors
Iris Pharma
Theradis pharma
NicOx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adenoplus test results | 21 days | AdenoPlus® test results, testing the studied eye at each post baseline visits. |
| 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 |
| 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 Subepithelial Corneal Infiltrates development | 21 days | For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator |
| 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) |
Countries
Spain
Outcome results
None listed