Overview

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

Status:
Completed
Trial end date:
2012-09-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Tetrahydrozoline
Criteria
Inclusion Criteria:

- Current use of an artificial tear product at least twice daily for at least 3 months,
on average

- Ability/agreement to continue wearing existing spectacle correction (glasses) during
study

Exclusion Criteria:

- Anticipated contact lens wear during study or contact lens use within 6 months

- Active ocular infection or allergy

- Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma
drops) within 2 weeks

- Use of any topical cyclosporine products within 3 months