Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) (Goldeneye)

NicOx

Status and phase

Withdrawn

Phase 2

Conditions

Adenoviral Conjunctivitis

Treatments

Drug: Carmellose

Drug: Iota-Carrageenan

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03009799

NCX-4240-15001

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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