UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of epinastine hydrochloride ophthalmic solution after switched from olopatadine hydrochloride ophthalmic solution in elderly patients with perennial allergic conjunctivitis.
Title of the study (Brief title)	Efficacy of epinastine hydrochloride ophthalmic solution in elderly patients with perennial allergic conjunctivitis.
Region	Japan

Condition
Condition	Perennial allergic conjunctivitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical evaluation of epinastine hydrochloride ophthalmic solution in elderly patients with perennial allergic conjunctivitis insufficiently controlled with olopatadine hydrochloride ophthalmic solution.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement rate of pruritus
Key secondary outcomes	Change in scores of subjective symptoms (at visits) Change in scores of objective findings (at visits) Change in scores of fluorescein corneal staining(at visits)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epinastine hydrochloride ophthalmic solution
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	55 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients aged 55 years or older 2)Patients diagnosed as perennial allergic conjunctivitis in the both eyes. 3)Patients with moderate or severe ocular pruritus and switching medication after treated with olopatadine hydrochloride ophthalmic solution for not less than two weeks at the time of informed consent.
Key exclusion criteria	1)Patients given immunotherapy (hyposensitization therapy, modulated therapy). 2)Patients with ocular pruritus and hyperemia caused by a disease other than allergic conjunctivitis which will influence drug evaluation. 3)Patients with a history of atopic keratoconjunctivitis, spring catarrh, giant papillary conjunctivitis, corneal herpes, recurrent corneal erosion caused by the frequent occurrence of corneal injury or dry eye. 4)Patients with surgical history in the internal eye (including laser therapy) within 90 days prior to initiation of the clinical research. 5)Patients with possibility taking medicines (including adrenal cortex steroid, anti-allergic agent and immunosuppressive drugs) which affect the efficacy of study drug. However, the use of ophthalmic solutions of adrenal cortex steroid is admitted as needed if there is no improvement in symptoms. 6)Females who are or may be pregnant, or lactating 7)Patients with a history of hypersensitivity to study drug or test material. 8)Patients with severe complications (such as immediate hospitalized care is required) which are identified inappropriate for safety reason. 9)Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study
Target sample size	20

Research contact person
Name of lead principal investigator	Kenji Inoue
Organization	Inouye Eye Hospital
Division name	Medical office
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Email	study@inouye-eye.or.jp

Public contact
Name of contact person	Kenji Inoue
Organization	Inouye Eye Hospital
Division name	Medical office
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Homepage URL
Email	study@inouye-eye.or.jp

Sponsor
Institute	Inouye Eye Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団　済安堂 お茶の水・井上眼科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 07 Day
Anticipated trial start date	2014 Year 11 Month 08 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 02 Day
Last modified on	2016 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018414