NCT01664949

A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Carboxymethylcellulose Based Eye Drop Formulation A	Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
DRUG	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-08-14
• Last updated: 2015-09-21
• Results posted: 2015-06-08

Locations

12 sites across 8 countries: Australia, Belgium, France, Germany, Italy, Russia, Spain, United Kingdom