UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030789 |
|---|---|
| Receipt number | R000035152 |
| 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 for pre-seasonal therapy |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2019/05/07 14:01:43 |
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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 for pre-seasonal therapy
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 for pre-seasonal therapy
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 for pre-seasonal therapy
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 for pre-seasonal therapy
Region
| Japan |
Condition
Condition
Seasonal allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in tear level of chemical mediators and expression of chemical mediator receptors on conjunctival epithelial cells in patient with seasonal allergic conjunctivitis for pre-seasonal therapy with epinastine hydrochloride ophthalmic solution
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in values of the following After 4weeks and 12weeks therapy
-Expression levels of chemical mediator receptor mRNA on conjunctival epithelial cells
-Levels of chemical mediator in tears
Key secondary outcomes
Change in values of the following After 4weeks and 12weeks therapy
-Subjective symptom scores
-Objective finding scores
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, for 12 weeks
Interventions/Control_2
Artificial tear, apply 2-3 drops a time, 5-6 times daily, for first 4 weeks and epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, for following 8 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient diagnosed with seasonal allergic conjunctivitis in the past
Positive result for cedar pollen antigen in an antigen-specific IgE examination in serum
Key exclusion criteria
Patient under immunotherapy (including hyposensitization therapy and allassotherapy)
Has history of allergy to the ingredients of the study drug and clinical reagents
Patient who the investigator considers ineligible for enrolment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Sugio |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9604
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital IRB
Address
2-15 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2018 | Year | 01 | 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
69
Results
69 cases (Epinastine Intervention Group; 35 cases, Switch from Artificial Tears to Epinastine Intervention Group; 34 cases) were enrolled.
As for both groups, expression levels of chemical mediator receptor mRNA on conjunctival epithelial cells were significantly increased at week 12 from the baseline (week 0).
As for both groups, levels of chemical mediation in tears were not changed significantly.
Through the study period, there were no side effects for both groups.
Results date posted
| 2019 | Year | 05 | Month | 07 | Day |
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
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035152
| Research Plan | |
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| Registered date | File name |
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