A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

Allergan

Status and phase: Completed; Phase 4

Conditions: Conjunctivitis, Allergic

Treatments: Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%; Drug: Alcaftadine 0.25%; Drug: Olopatadine 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01732757

GMA-LAS-12-023

Details and patient eligibility

About

This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.

Enrollment: 157 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of ocular allergies within the past 24 months.
• Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion criteria

• Any presence of active ocular infection or history of an ocular herpetic infection.
• Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
• Have any planned surgery during the study or 30 days after the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 3 patient groups, including a placebo group

Lastacaft®

Active Comparator group

Description:

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Treatment:

Drug: Alcaftadine 0.25%

Pataday™

Active Comparator group

Description:

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Treatment:

Drug: Olopatadine 0.2%

Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

Placebo Comparator group

Description:

One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Treatment:

Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%