UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056448 |
|---|---|
| Receipt number | R000064505 |
| Scientific Title | A Study of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% for Seasonal Allergic Conjunctivitis |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2024/12/18 15:47:04 |
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Basic information
Public title
A Study of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% for Seasonal Allergic Conjunctivitis
Acronym
A Study of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% for Seasonal Allergic Conjunctivitis
Scientific Title
A Study of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% for Seasonal Allergic Conjunctivitis
Scientific Title:Acronym
A Study of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% for 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 explore the efficacy of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% and Epinastine Hydrochloride Ophthalmic Solution 0.1% in patients with seasonal allergic conjunctivitis in spring.
As a reference, to explore the effect of different starting times of administration with epinastine hydrochloride eyelid cream 0.5%.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy endpoints
Subjective symptoms and QOL score
Safety endpoints
Adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects diagnosed with seasonal allergic conjunctivitis in spring before 2024
Subject with seasonal allergic conjunctivitis who visited the eye clinic between the date of signing the contract and February 14, 2025 (before the full-scale dispersal of pollen) requested and were prescribed Epinastine Hydrochloride Eyelid Cream 0.5% or Epinastine Hydrochloride Ophthalmic Solution 0.1% as preseasonal treatment
Subjects with seasonal allergic conjunctivitis who visited the eye clinic due to symptoms such as itchy eyes between February 24 and March 24, 2025 requested and were prescribed Epinastine Hydrochloride Eyelid Cream 0.5%
Key exclusion criteria
Subjects with severe allergic conjunctival disease (VKC, atopic keratoconjunctivitis)
Of the Subjects with seasonal allergic conjunctivitis who visited the eye clinic due to symptoms such as itchy eyes between February 24 and March 24, 2025 requested and were prescribed Epinastine Hydrochloride Eyelid Cream 0.5%, those who used antihistamine eye drops since the end of 2024 up to the time of obtaining consent.
Subjects prescribed Epinastine Hydrochloride Eyelid Cream 0.5% who have obvious inflammatory findings on the eyelid skin Subjects with severe allergic conjunctival disease (VKC, atopic keratoconjunctivitis)
Of the Subjects with seasonal allergic conjunctivitis who visited the eye clinic due to symptoms such as itchy eyes between February 24 and March 24, 2025 requested and were prescribed Epinastine Hydrochloride Eyelid Cream 0.5%, those who used antihistamine eye drops since the end of 2024 up to the time of obtaining consent.
Subjects prescribed Epinastine Hydrochloride Eyelid Cream 0.5% who have obvious inflammatory findings on the eyelid skin
Subjects prescribed Epinastine Hydrochloride Eyelid Cream 0.5% with symptoms and findings of atopic dermatitis on the face
Subjects prescribed Epinastine Hydrochloride Eyelid Cream 0.5% who are using prescription drugs (steroid eye ointments, steroid ointments, immunosuppressants, etc.) on the eyelid skin
Subjects using steroid eye drops or steroid eye ointment
Target sample size
210
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
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 | Hirotsugu |
| Middle name | |
| Last name | Kishimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
03-4802-9337
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
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
03-6779-8166
chi-pr-ec-hillside@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
| 2024 | Year | 12 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-institutional, prospective observational study
To explore the efficacy of preseasonal treatment with Epinastine Hydrochloride Eyelid Cream 0.5% and Epinastine Hydrochloride Ophthalmic Solution 0.1% in patients with seasonal allergic conjunctivitis in spring.
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064505
