Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate; Olopatadine Hydrochloride; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

Exclusion Criteria:

• Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.

• Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.

• Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.

• Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.