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

Condition(s) targeted: Allergic Conjunctivitis

Intervention: DE-114 ophthalmic solution (Drug); Placebo ophthalmic solution (Drug); Olopatadine Hydrochloride 0.1% Ophthalmic Solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Santen Pharmaceutical Co., Ltd.

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.

Official title: Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -

Study design: N/A

Primary outcome:

Mean Ocular Itching Score Compared to Placebo Period1

Mean Hyperemia Score Compared to Placebo Period1

Secondary outcome:

Mean Ocular Itching Score Compared to Olopatadine Period2

Mean Hyperemia Score Compared to Olopatadine Period2

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Provided signed, written informed consent.

- Has a positive result from an allergen-specific IgE antibody test.

- If a subject is a female of childbearing potential, she must utilize reliable

contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria:

- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing

potential who are not using a reliable method of contraception.

- Presence of any abnormality or significant illness that could be expected to

interfere with the study.

Santen study sites, Osaka, Japan

Last updated: November 5, 2014