Goldeneye: Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Eye drops containing Iota-Carrageenan Eye drops 3.2mg/ml |
Drug: Iota-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
Other Names:
|
| Placebo Comparator: Ocular Lubricant Eye Drops Carmellose 0.5% sterile solution |
Drug: Carmellose
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test
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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:
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Negative results with adenoplus test in both eyes
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a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- NicOx
- Iris Pharma
- Theradis pharma
Investigators
- Study Director: Brigitte Duquesroix, NicOx
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCX-4240-15001