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

• Status: Withdrawn
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NicOx
• Collaborators: Iris Pharma; Theradis pharma
• Treatments: Carboxymethylcellulose Sodium; Ophthalmic Solutions; Tetrahydrozoline

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