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

Overview

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).

Full Title of Study: “A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 2011

Interventions

  • Drug: Loteprednol etabonate 0.2%
    • 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
  • Drug: Olopatadine 0.1%
    • 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Arms, Groups and Cohorts

  • Experimental: Alrex
    • Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
  • Active Comparator: Patanol
    • Ophthalmic solution containing olopatadine, 0.1%

Clinical Trial Outcome Measures

Primary Measures

  • Bulbar Conjunctival Injection
    • Time Frame: Change from baseline to day 15 (visit 3)
    • Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
  • Ocular Itching
    • Time Frame: Change from baseline to day 15 (visit 3)
    • Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe

Secondary Measures

  • Bulbar Conjunctival Injection
    • Time Frame: Change from baseline to day 8 (visit 2)
    • Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
  • Ocular Itching
    • Time Frame: Change from baseline to day 8 (visit 2)
    • Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Esther Chu, Study Director, Bausch & Lomb Incorporated

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