Trial | NCT03009799  Report issue

Title

Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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:

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.
Study Started
Jan 31
2017
Primary Completion
Aug 31
2017
Anticipated
Study Completion
Sep 30
2017
Anticipated
Last Update
May 10
2017

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: NCX-4240

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: Placebo

Eye drops containing Iota-Carrageenan Active Comparator

Eye drops 3.2mg/ml

Ocular Lubricant Eye Drops Placebo Comparator

Carmellose 0.5% sterile solution

Criteria 

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
No Results Posted