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

Phase 3 Completed 300 enrolled Bausch & Lomb Incorporated

RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start: 2010-08
Primary completion: 2011-04
Completion: 2011-05

Outcome

Met primary endpoint

paper Treatment differences in CFB were significantly better with LE compared with olopatadine for both end points (P ≤ 0.0006). PMID 22627057 ↗

paper The 95% CI for the differences in CFB in ocular itching (-0.59 to -0.27) and bulbar conjunctival injection (-0.27 to -0.08) was less than the prespecified noninferiority limit of 0.3. PMID 22627057 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loteprednol Etabonate	Other / unclassified	0.2 %	Other
Comparator	Olopatadine	Other / unclassified	0.1 %	Other