Safety and Efficacy Study of a Eye Drop for Eye Allergy

NCT00889330 ↗

Phase 3 Completed 60 enrolled Vistakon Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Timeline

Start: 2009-04
Primary completion: 2009-05
Completion: —

Outcome

Met primary endpoint

paper Alcaftadine was effective in the prevention of ocular itching based on both clinically relevant and statistically significant differences compared with vehicle (placebo). PMID 21250860 ↗

paper Alcaftadine significantly reduced conjunctival redness, and almost all other allergic signs and symptoms at both 15 minutes and 16 hours after drug administration. PMID 21250860 ↗

Publications

Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alcaftadine	Small molecule	0.25 %	Other