UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062737 |
|---|---|
| Receipt number | R000070687 |
| Scientific Title | Efficacy and safety of 0.5% epinastine ophthalmic solution cream |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/30 10:04:34 |
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Basic information
Public title
Efficacy and safety of 0.5% epinastine ophthalmic solution cream in patients of allergic conjunctivitis
Acronym
Efficacy and safety of 0.5% epinastine ophthalmic solution cream
Scientific Title
Efficacy and safety of 0.5% epinastine ophthalmic solution cream
Scientific Title:Acronym
Efficacy and safety of 0.5% epinastine ophthalmic solution cream
Region
| Japan |
Condition
Condition
Patients with allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of 0.5% epinastine ophthalmic solution cream
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
efficacy
Key secondary outcomes
safety
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received a full explanation on the objects and methods of this study, expected effects and adverse drug reactions, respect for the compensation, and who themselves of their legal representative voluntarily proved consent for study participation.
Key exclusion criteria
Patients whom the research doctor judged to be unsuitable for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fujishima |
Organization
Tsurumi University
Division name
Dentistry
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumiku, Yokohama-shi, Japan
TEL
0455808599
fujishima117@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fujishima |
Organization
Tsurumi University
Division name
Dentistry
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Japan
TEL
0455808599
Homepage URL
fujishima117@gmail.com
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Hiroshi Fujishima
Funding Source
Organization
Tsurumi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University
Address
2-1-3 Tsurumi, Tsurum-ku, Yokohama-shi, Japan
Tel
0455808599
fujishima117@gmail.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
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
Purpose: We studied the effectiveness of Allegion cream for allergic conjunctivitis.
Methods: We studied 200 eyes from 200 people, scored conjunctival redness according to the guidelines, and then evaluated the scores at certain points after starting the cream treatment.
Results: Significant improvement was seen after one week of treatment. Effective results were maintained throughout the month. Two people experienced worsening eyelid inflammation.
Results date posted
| 2026 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Blepharitis
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2026 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 01 | Day |
Other
Other related information
Cases that were stopped at the patient's request are excluded.
Management information
Registered date
| 2026 | Year | 08 | Month | 30 | Day |
Last modified on
| 2026 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070687
