UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056319 |
|---|---|
| Receipt number | R000064352 |
| Scientific Title | Therapeutic efficacy of Epinastine Hydrochloride Eyelid Cream 0.5% in the treatment of allergic conjunctival disease. |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/11/30 11:43:57 |
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Basic information
Public title
Therapeutic efficacy of Epinastine Hydrochloride Eyelid Cream 0.5% in the treatment of allergic conjunctival disease.
Acronym
Therapeutic efficacy of Epinastine Hydrochloride Eyelid Cream 0.5% in the treatment of allergic conjunctival disease.
Scientific Title
Therapeutic efficacy of Epinastine Hydrochloride Eyelid Cream 0.5% in the treatment of allergic conjunctival disease.
Scientific Title:Acronym
Therapeutic efficacy of Epinastine Hydrochloride Eyelid Cream 0.5% in the treatment of allergic conjunctival disease.
Region
| Japan |
Condition
Condition
allergic conjunctival disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the therapeutic efficacy of 0.5% epinastine topical eyelid cream in the treatment of allergic conjunctival disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Change in subjective symptom score (JACQLQ)
2.Changes in objective symptom score (JACQLQ)
3.Changes in conjunctival injection score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.5% epinastine topical eyelid cream
Interventions/Control_2
antiallergic eye drops
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with allergic conjunctivitis disease
Key exclusion criteria
1 Patients with a past history of ocular surgery.
2. Patient who can not use eye drops.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mimura |
| Middle name | |
| Last name | Tatsuya |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
mimurat-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mimura |
| Middle name | |
| Last name | Tatsuya |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
0339641211
Homepage URL
mimurat-tky@umin.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology Tsurumi University Dental Hospital, Ryogoku Eye Clinic, Fujishima Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Teikyo University
Address
2-11-1 Kaga Itabashi-ku
Tel
0339641211
mimurat-tky@umin.ac.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
帝京大学医学部付属病院眼科（東京都）、鶴見大学歯学部附属病院眼科（神奈川県）、両国眼科クリニック（東京都）、藤島眼科医院（新潟県）、練馬駅西口眼科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064352
