NCT01294384

Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	carboxymethylcellulose sodium based New Eye Drop Formulation 1	1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
DRUG	carboxymethylcellulose sodium based New Eye Drop Formulation 2	1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
DRUG	carboxymethylcellulose sodium based Eye Drops	1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-25
• Completion: 2012-09-25
• First posted: 2011-02-11
• Last updated: 2019-04-16
• Results posted: 2013-11-25

Locations

2 sites across 2 countries: Australia, Canada