UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036118 |
|---|---|
| Receipt number | R000041095 |
| Scientific Title | Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis |
| Date of disclosure of the study information | 2019/03/12 |
| Last modified on | 2019/10/04 10:49:05 |
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Basic information
Public title
Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Acronym
Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Scientific Title
Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Scientific Title:Acronym
Questionnaire survey on use of anti- allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Region
| Japan |
Condition
Condition
seasonal allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ask a questionnaire for patients with seasonal allergic conjunctivitis.
Basic objectives2
Others
Basic objectives -Others
Relationship between drug adherence status and background of Patients
Effect of treatment satisfaction and QOL with ophthalmic solutions adherence status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between drug adherence status and background of Patients
Effect of treatment satisfaction and QOL with ophthalmic solutions adherence status
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects diagnosed with seasonal allergic conjunctivitis by ophthalmologist and used of anti-allergic ophthalmic solutions after the end of 2018.
Subjects with seasonal allergic conjunctivitis such as eye itch after the end of 2018.
Key exclusion criteria
Medical staff (including doctor, pharmacist, nurse)
Subjects engaged in pharmaceuticals and medical devices industry
Subjects engaged in pharmaceuticals distributor
Subjects engaged in information provision service , research and advertisement industry
Subjects with severe allergic conjunctivitis (vernal keratoconjunctivitis , atopic keratoconjunctivitis )
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naruhiro |
| Middle name | |
| Last name | Ishida |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Otsuka |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo
Tel
070-5011-8550
shingo-namiki@j-smo.com
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
| 2019 | Year | 03 | Month | 12 | 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
1008
Results
Patients with good adherence for usage was 4.0%.
The total QOL score was significantly lower in the good adherence patients group than in the poor adherence patients group(p<0.0001).
Results date posted
| 2019 | Year | 10 | Month | 04 | 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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey on use of anti-allergic ophthalmic solutions for patients with seasonal allergic conjunctivitis
Management information
Registered date
| 2019 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041095
