NCT02553772

A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Carboxymethylcellulose Based Eye Drop	Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
DRUG	Carboxymethylcellulose Sodium 0.5%	Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Timeline

• Start date: 2016-01-06
• Primary completion: 2016-09-09
• Completion: 2016-09-09
• First posted: 2015-09-18
• Last updated: 2017-11-17
• Results posted: 2017-11-17

Locations

13 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study