A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: REFRESH LIQUIGEL®; Drug: Refresh Optive® Gel Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280473

11193X-001

Details and patient eligibility

About

This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current use of an artificial tear product
• Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion criteria

• Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
• Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
• Current eye infection or inflammation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Refresh Optive® Gel Drops

Experimental group

Description:

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Treatment:

Drug: Refresh Optive® Gel Drops

REFRESH LIQUIGEL®

Active Comparator group

Description:

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Treatment:

Drug: REFRESH LIQUIGEL®