Clinical Trial: Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis
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 Summary:
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.
Sponsor: NicOx
Current Primary Outcome: Viral eradication time NCX 4240 versus Placebo [ Time Frame: 21 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quantitative PCR [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 21 days ]AdenoPlus® test results, testing the studied eye at each post baseline visits.
- Investigator's assessment of Membranes and pseudomembranes development [ Time Frame: 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 [ Time Frame: 21 days ]For both eyes: timing of occurrence if any
- Investigator's assessment of Subepithelial Corneal Infiltrates development [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Same as current
Information By: NicOx
Dates:
Date Received: December 12, 2016
Date Started: January 2017
Date Completion: September 2017
Last Updated: May 9, 2017
Last Verified: May 2017