UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013173 |
|---|---|
| Receipt number | R000014636 |
| Scientific Title | Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system. |
| Date of disclosure of the study information | 2014/02/16 |
| Last modified on | 2017/02/21 01:46:50 |
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Basic information
Public title
Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Acronym
Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases.
Scientific Title
Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Scientific Title:Acronym
Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases.
Region
| Japan |
Condition
Condition
Allergic conjunctival diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of efficacy of anti-allergic ophthalmic solution in allergic conjunctival diseases using allergic conjunctival diseases medical treatment assessment system consisting of symptom score, objective score and ocular surface clinical examinations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparative study on therapeutic efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using allergic conjunctival diseases therapeutic assessment system.
Key secondary outcomes
Investigation of useful biomarker in tears or ocular surface for allergic conjunctival disease practice by the comparison between objective finding and ocular surface clinical examination.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epinastine hydrochloride ophthalmic solution
Interventions/Control_2
Sodium cromoglicate ophthalmic solution
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
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with allergic conjunctival diseases
1) Male or female of age of 4 years or older.
2) Patients who provided written informed consent for participating in this study.
3) Patients who are diagnosed as allergic conjunctival diseases according to the guideline for allergic conjunctival diseases in Japan.
Key exclusion criteria
1) Patients with anterior segment disease (including blepharitis, lagophthalmos, blepharospasm, iritis and conjunctivochalasis) other than allergic conjunctival diseases at the study initiation.
2) Patients who cannot discontinue eye drops (include all eye drops such as prescribed drug and OTC medicine) except for the study drug or the control drug from the study initiation until the end of study treatment or who expect to use those drugs
3) Patients with a history of surgery of the ocular surface within 12 months or patients with a history of intraocular surgery within three months prior to the study drug initiation examination.
4) Patients who have difficulty in sampling.
5) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Shoji |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
Address
30-1 Oyaguchi-kacho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
shojig3589eye@athena.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Shoji |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
Address
30-1 Oyaguchi-kacho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
shojig3589eye@athena.ocn.ne.jp
Sponsor or person
Institute
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Institute
Department
Personal name
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
Shoji Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本大学医学部付属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 16 | 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
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
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014636
