Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Allergan

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Drug: Glycerin and Polysorbate 80 based artificial tear; Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear; Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932477

AG9965-001

Details and patient eligibility

About

The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild, moderate or severe symptoms of dry eye

Exclusion criteria

• Uncontrolled systemic disease
• Contact lens wear
• Participation in another clinical study

Trial design

47 participants in 3 patient groups

Artificial Tear Formulation 1

Experimental group

Description:

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Treatment:

Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Artificial Tear Formulation 2

Experimental group

Description:

Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Treatment:

Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Glycerin and Polysorbate 80 based artificial tear

Active Comparator group

Description:

Glycerin and Polysorbate 80 based artificial tear

Treatment:

Drug: Glycerin and Polysorbate 80 based artificial tear