UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Title of the study (Brief title)	Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Region	Japan

Condition
Condition	Allergic conjunctivitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical efficacy of epinastine hydrochloride ophthalmic solution in the patients wearing contact lenses with allergic conjunctivitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in scores of subjective symptoms Change in scores of objective findings
Key secondary outcomes

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, apply 1 drop a time, 4 times daily, for 8 weeks
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

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who has a positive result of type I allergy test by immuno-cap rapid 2)The planned patient who wears the contact lenses of the same product during a study
Key exclusion criteria	1)The patient at the start of the test, it is determined that the continuously during the test period should not wear contact lenses 2)Females who are or may be pregnant, or lactating 3)Patients with a history of hypersensitivity to study drug or test material 4)Patient who the investigator considers ineligible for enrolment
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Kamezawa
Organization	Kamezawa EYE CLINIC
Division name	Kamezawa EYE CLINIC
Address	Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama
TEL	045-731-1113
Email	kamezawa-ganka@pearl.ocn.ne.jp

Public contact
Name of contact person	Hiroshi Kamezawa
Organization	Kamezawa EYE CLINIC
Division name	Kamezawa EYE CLINIC
Address	Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama
TEL	045-731-1113
Homepage URL
Email	kamezawa-ganka@pearl.ocn.ne.jp

Sponsor
Institute	Kamezawa EYE CLINIC
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	50 patients with allergic conjunctivitis wearing CL were instilled for 8 weeks with BAK-free epinastine hydrochloride ophthalmic solution, and clinical efficacy and safety were examined. Itchy eye, conjunctival hyperemia and staining score of kerato and conjunctival membrane were significantly improved by ocular instillation on CL wearing, which results were similar to the previous reports. Ocular instillation on CL wearing highly satisfied the patients with allergic conjunctivitis, which resulted in the CL wearing time extended to the same level as before the morbidity.Furthermore, eye drop instillation on CL wearing didn't have harmful effects on CL fitting, there were no adverse events such as corneal and conjunctival epithelial disorder, which suggested no concern in safety. From the above results, it can be expected that ocular instillation on CL wearing with epinastine hydrochloride ophthalmic solution can be a treatment for improving the symptoms and clinical findings of allergic conjunctivitis without impairing safety and increasing patient satisfaction.
Other related information

Management information
Registered date	2015 Year 01 Month 23 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018933