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

Adenoviral Conjunctivitis Clinical Trial

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

Status Withdrawn

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenoviral Conjunctivitis
• Conjunctivitis

• NCT number: NCT03009799
• Study type: Interventional
• Source: NicOx
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2017
• Completion date: September 2017