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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Conjunctivitis

Treatments: Drug: Olopatadine 0.1%; Drug: Loteprednol etabonate 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435460

634

Details and patient eligibility

About

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).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Alrex

Experimental group

Description:

Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%

Treatment:

Drug: Loteprednol etabonate 0.2%

Patanol

Active Comparator group

Description:

Ophthalmic solution containing olopatadine, 0.1%

Treatment:

Drug: Olopatadine 0.1%