Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

Phase 3 Completed 87 enrolled Santen Pharmaceutical Co., Ltd.

Summary

The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.

Timeline

Start: —
Primary completion: 2012-06
Completion: —

Outcome

Met primary endpoint

registry Epinastine (DE-114) Ophthalmic Solution vs Placebo Ophthalmic Solution; p <0.001; Mean Difference (Final Values) -1.3 (95% CI -1.52 to -1.11) NCT01363700 ↗

registry Epinastine (DE-114) Ophthalmic Solution vs Placebo Ophthalmic Solution; p <0.001; Mean Difference (Final Values) -1.3 (95% CI -1.71 to -0.92) NCT01363700 ↗

paper For the primary end point, epinastine showed superiority to placebo for the inhibition of ocular itching and conjunctival hyperemia induced at 4 hours PMID 25163405 ↗

Publications

Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epinastine	Small molecule	0.05 %	Other
Comparator	Olopatadine	Other / unclassified	0.1 %	Other