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

Glaucoma Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02003547
Study type Interventional
Source Amakem, NV
Contact
Status Completed
Phase Phase 1
Start date September 2013
Completion date December 2013
View Details
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