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)
Sponsor study identifier
interventional
300
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 2011
Actual (reported)May 2011
Actual (reported)September 14, 2011
Actual (reported)September 16, 2011
Actual (reported)March 13, 2012
Actual (reported)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)
Bulbar Conjunctival Injection
Change from baseline to day 8 (visit 2)
Ocular Itching
Change from baseline to day 8 (visit 2)
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Ophthalmic solution containing olopatadine, 0.1%
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
Bausch & Lomb Singapore
Singapore, Singapore, 556741, Singapore
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.
Esther Chu
Bausch & Lomb Incorporated
300 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2011
First Posted
September 16, 2011
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
March 13, 2012
Results First Posted
March 13, 2012
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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