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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016310
Receipt No. R000018933
Scientific Title Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Date of disclosure of the study information 2015/02/01
Last modified on 2017/08/18

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Basic information
Public title Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Acronym Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Scientific Title Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kamezawa
Organization Kamezawa EYE CLINIC
Division name Kamezawa EYE CLINIC
Zip code
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
1st name
Middle name
Last name Hiroshi Kamezawa
Organization Kamezawa EYE CLINIC
Division name Kamezawa EYE CLINIC
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 17 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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