NCT01459588

Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Carboxymethylcellulose Based Eye Drop Formulation A	Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
DRUG	Carboxymethylcellulose Based Eye Drop Formulation B	Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
DRUG	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
DRUG	Carboxymethylcellulose Based Lubricant Eye Drops	Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-02-15
• Completion: 2012-02-15
• First posted: 2011-10-25
• Last updated: 2019-04-16
• Results posted: 2013-03-14

Locations

1 site across 1 country: United States