A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Shire

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Lifitegrast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02284516

SHP606-304

Details and patient eligibility

About

Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Enrollment: 711 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient-reported history of Dry Eye Disease in both eyes.
• Use of over the counter artificial tears within the past 30 days.
• A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
• Able and willing to comply with all study procedures.

Exclusion criteria

• Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
• Unwilling to stop wearing contact lenses during the study.
• LASIK or other ocular surgical procedures within 12 months prior to or during the study.
• Use of prohibited medications
• Significant medical conditions that could affect the study parameters.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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711 participants in 2 patient groups, including a placebo group

Lifitegrast

Experimental group

Description:

Lifitegrast Ophthalmic Solution 5%, BID for 84 days

Treatment:

Drug: Lifitegrast

Placebo

Placebo Comparator group

Description:

Placebo to match active treatment, BID for 84 days

Treatment:

Drug: Placebo