Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
ClinicalTrials.gov ID
NCT01294384
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
305Actual
Last Update Posted
Apr 16, 2019Actual
Start Date
May 1, 2011Actual
Primary Completion Date
Sep 25, 2012Actual
Completion Date
Sep 25, 2012Actual
Brief 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.
Dry Eye Syndromes
carboxymethylcellulose sodium based New Eye Drop Formulation 1
carboxymethylcellulose sodium based New Eye Drop Formulation 2
carboxymethylcellulose sodium based Eye Drops
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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