UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039554 |
|---|---|
| Receipt number | R000045106 |
| Scientific Title | Effects of subjective symptoms and quality of life by the adherence with anti-histamine ophthalmic solution in patients with seasonal allergic conjunctivitis - A multicenter, prospective, cross-sectional study - |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2023/03/09 15:08:24 |
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Basic information
Public title
Effects of subjective symptoms and quality of life by the adherence with anti-histamine ophthalmic solution in patients with seasonal allergic conjunctivitis - A multicenter, prospective, cross-sectional study -
Acronym
Cross-sectional study about the adherence with anti-histamine ophthalmic solution in patients with seasonal allergic conjunctivitis
Scientific Title
Effects of subjective symptoms and quality of life by the adherence with anti-histamine ophthalmic solution in patients with seasonal allergic conjunctivitis - A multicenter, prospective, cross-sectional study -
Scientific Title:Acronym
Cross-sectional study about the adherence with anti-histamine ophthalmic solution in 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
To ask a questionnaire for patients with seasonal allergic conjunctivitis who visited the eye clinic for a specified period and were prescribed anti-histamine ophthalmic solution, and to assess the subjective symptoms and quality of life by the adherence.
Basic objectives2
Others
Basic objectives -Others
Effect of subjective symptoms and QOL with ophthalmic solutions adherence status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of subjective symptoms and QOL with ophthalmic solutions adherence status
Key secondary outcomes
Base
Study type
Observational
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
Patient diagnosed with seasonal allergic conjunctivitis in spring before 2019
Patient who has been prescribed anti-histamine ophthalmic solution on the day of informed consent.
Key exclusion criteria
Patient with severe allergic conjunctival disease (VKC, atopic keratoconjunctivitis)
Patient who received treatment before pollen dispersal for seasonal allergic conjunctivitis after the end of 2019
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Hori |
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 | Hirotsugu |
| Middle name | |
| Last name | Kishimoto |
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@cmicgroup.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
| 2020 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s12325-022-02324-w
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12325-022-02324-w
Number of participants that the trial has enrolled
418
Results
The improvement of the overall QOL scale score in the proactive use group after propensity score matching was significantly greater than that in the as-needed use group (P = 0.002).
The twice-daily eye formulations significantly improved QOL in "outdoor activities" and "social life" compared to the four-times-daily formulations, (Allergy no Rinsyo [Allergy Pract]. 2021;41(8):37-46)
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 26 | 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
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective observational study
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045106
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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