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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]

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.


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