UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020490 |
|---|---|
| Receipt number | R000023659 |
| Scientific Title | Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis |
| Date of disclosure of the study information | 2016/01/15 |
| Last modified on | 2017/03/29 05:54:52 |
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Basic information
Public title
Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis
Acronym
Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis
Scientific Title
Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis
Scientific Title:Acronym
Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis
Region
| Japan |
Condition
Condition
Allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore changes in tear level of chemical mediators and expression of chemical mediator receptors on conjunctival epithelial cells in patient with allergic conjunctivitis for pre-seasonal therapy with anti-allergic ophthalmic solution
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression levels and change in values after 4weeks and 12weeks therapy of chemical mediator receptors on conjunctival epithelial cells
Key secondary outcomes
After 4weeks and 12weeks therapy measured values and change in values of the following
Subjective symptom scores
Objective finding scores
Tear levels of chemical mediators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epinastine ophthalmic solution, apply 1 drop a time, 4 times daily, for 12 weeks
Interventions/Control_2
Olopatadine ophthalmic solution, apply 1 drop a time, 4 times daily, for 12 weeks
Interventions/Control_3
Artificial tear, apply 2-3 drops a time, 5-6 times daily, for 4 weeks and Epinastine ophthalmic solution, apply 1 drop a time, 4 times daily, for 8 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who has a positive result of type I allergy test by immuno-cap rapid.
Key exclusion criteria
1.Females who are or may be pregnant, or lactating
2.Patients with a history of hypersensitivity to study drug or test material
3.Patient who the investigator considers ineligible for enrolment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1, Seiryo-cho Aobaku, Sendai city, Miyagi
TEL
022-717-7000
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuichi Maruyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1, Seiryo-cho Aobaku, Sendai city, Miyagi
TEL
022-717-7000
Homepage URL
maruyama-k@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate 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
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023659
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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