UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050732 |
|---|---|
| Receipt number | R000057793 |
| Scientific Title | A web-based survey on itching in patients with seasonal allergic conjunctivitis in 2023 |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/07/03 17:20:14 |
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Basic information
Public title
A web-based survey on itching in patients with seasonal allergic conjunctivitis in 2023
Acronym
A web-based survey on itching in patients with seasonal allergic conjunctivitis in 2023
Scientific Title
A web-based survey on itching in patients with seasonal allergic conjunctivitis in 2023
Scientific Title:Acronym
A web-based survey on itching in patients with seasonal allergic conjunctivitis in 2023
Region
| Japan |
Condition
Condition
seasonal allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ask a questionnaire for patients with seasonal allergic conjunctivitis.
Basic objectives2
Others
Basic objectives -Others
To investigate the situation of eye itch and the relationship between eye itch and eye drop behavior in patients with seasonal allergic conjunctivitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The situation of eye itch
The relationship between eye itch and eye drop behavior
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects diagnosed with seasonal allergic conjunctivitis by an ophthalmologist and prescribed anti histamine eye drops after December 2022.
Subjects with itchy eyes associated with seasonal allergic conjunctivitis in at least one eye after December 2022.
Key exclusion criteria
Medical professionals (doctors, pharmacists, nurses, etc.)
Subjects engaged in pharmaceuticals and medical devices industry
Subjects engaged in pharmaceuticals distributor
Subjects engaged in information provision services, research services, and advertising
Subjects with severe allergic conjunctival disease (vernal keratoconjunctivitis , atopic keratoconjunctivitis)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Miyahara |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
5308552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kishimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
5308552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
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 Institutions Sapporo Yuurinokai Hospital Clinical Trials Committee
Address
Kita-ku, Sapporo-shi Hokkaido Hokkaido 11 chome 186
Tel
011-771-1501
info@yurinokai.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
| 2023 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Published
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
1050
Results
The most common areas that felt itchy was the corner of the eye and the skin on the side of the nose. (Allergy Practice,2023 43(13): 1034-1046)
Most patients with seasonal allergic conjunctivitis had symptoms on the eyelid skin, but few were treated. (Allergy Practice, 2024 44(3): 218-228)
The use of proactive antihistamine eye drops was higher for the twice-daily formulation than for the four times-daily formulation. (Allergy Practice, 2024 44(4):284-293)
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 22 | Day |
Baseline Characteristics
Refer to published paper
Participant flow
Refer to published paper
Adverse events
Refer to published paper
Outcome measures
Refer to published paper
Plan to share IPD
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
IPD sharing Plan description
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web-based survey of patients diagnosed with seasonal allergic conjunctivitis at an ophthalmologist
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057793
