Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

Allergan

Status

Completed

Conditions

Dry Eye Syndrome

Treatments

Drug: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear

Drug: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear

Drug: Glycerin and Polysorbate 80 based artificial tear

Study type

Interventional

Funder types

Industry

Identifiers

NCT01010282

AG9965-002

Details and patient eligibility

About

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

Enrollment

288 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
Ability/agreement to wear habitual correction (glasses) during study period

Exclusion criteria

Known allergy or sensitivity to the study product(s) or its components
Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
Chronic use of systemic medications which may affect a dry eye condition
Active ocular allergy or infection
Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.