NCT02003547

A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects

A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Amakem, NV · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects

Detailed description

Each subject will receive the following treatments: * Period 1: Formulation A (n = 14) or placebo (n = 7) twice daily for 7 days * Period 2: Formulation B (n = 14) or placebo (n = 7) twice daily for 7 days * Period 3: Formulation C (n = 14) or placebo (n = 7) twice daily for 7 days There will be a minimum washout of 7 days between each treatment period (last dose of previous period to first dose of subsequent period

Conditions

• Glaucoma
• Ocular Hypertension
• Eye Disease

Interventions

Type	Name	Description
DRUG	AMA0076
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-12-06
• Last updated: 2014-05-02

Locations

1 site across 1 country: United Kingdom