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

Santen Pharmaceutical Co., Ltd.130 enrolled

Overview

Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.

Study Type

INTERVENTIONAL

Enrollment

130

Conditions

Allergic Conjunctivitis

Interventions

DE-114 ophthalmic solutionDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provided signed, written informed consent. * Has a positive result from a Type I allergy 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.

Locations (1)

Santen study sites

Osaka, Japan

Outcomes

Primary Outcomes

Change in Ocular Itching Score by Visit

Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

Time frame: From baseline to 8-week

Data from ClinicalTrials.gov

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