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

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)

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).

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Conjunctivitis
• Intervention / Treatment: Drug: Loteprednol etabonate 0.2%; Drug: Olopatadine 0.1%

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 556741
    • Bausch & Lomb Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alrex; Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Drug: Loteprednol etabonate 0.2%; 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.; Other Names: Alrex
Active Comparator: Patanol; Ophthalmic solution containing olopatadine, 0.1%	Drug: Olopatadine 0.1%; 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.; Other Names: Patanol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Esther Chu, Bausch & Lomb Incorporated

Publications and helpful links

General Publications

• Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (Estimate): September 16, 2011

Study Record Updates

• Last Update Posted (Estimate): March 13, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: ocular allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Loteprednol Etabonate; Olopatadine Hydrochloride
• Other Study ID Numbers: 634