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

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: carboxymethylcellulose sodium based Eye Drops; Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1; Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294384

10078X-001

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

305 participants in 3 patient groups

New Eye Drop Formulation 1

Experimental group

Description:

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.

Treatment:

Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1

New Eye Drop Formulation 2

Experimental group

Description:

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.

Treatment:

Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2

Refresh Tears®

Active Comparator group

Description:

1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Treatment:

Drug: carboxymethylcellulose sodium based Eye Drops