UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026105 |
|---|---|
| Receipt number | R000029348 |
| Scientific Title | Treatment with anti-histamine ointment on eyelids for allergic conjunctivitis |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2019/07/18 20:39:08 |
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Basic information
Public title
Treatment with anti-histamine ointment on eyelids for allergic conjunctivitis
Acronym
Anti-histamine ointment on eyelids for allergic conjunctivitis
Scientific Title
Treatment with anti-histamine ointment on eyelids for allergic conjunctivitis
Scientific Title:Acronym
Anti-histamine ointment on eyelids for allergic conjunctivitis
Region
| Japan |
Condition
Condition
allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of trans-dermal application of diphenhydramine ointment over the eyelids in the patients with allergic conjunctivitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Subjective effectiveness by the patients, 2 weeks after the introduction of the therapy.
Key secondary outcomes
adverse effects (vision test, intraocular pressure)
objective effectiveness judged by clinicians.
QOL.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diphenhydramine ointment of 1/4 Finger tip units will be applied to each eyelid twice a day for 2 weeks.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
# Patients with allergic conjunctivitis.
# Persistent symptoms despite the conventional treatment such as anti-histamine topically or orally given.
# No change of drugs 4 weeks prior to the enrollment.
Key exclusion criteria
# Those with underlying dermal disease of eyelids such as atopic dermatitis.
# Those with newly introdeced anti-allergic, anti-histamine, steroids.
# Patients with pregnancy and lactation.
# Those whom the attending clinicians regard to be unsuitable to the enrollment to the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of pulmonology
Zip code
190-0014
Address
Midorimachi 3256, Tachikawa, Tokyo
TEL
042-526-5511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of pulmonology
Zip code
190-0014
Address
Midorimachi 3256, Tachikawa, Tokyo
TEL
042-526-5511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Department of pulmonology
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Disaster Medical Center
Department of pulmonology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Pharmaceutical Sciences, Josai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Disaster Medical Center
Address
Midorimachi 3256, Tachikawa, Tokyo
Tel
042-526-5511
tdmckamimura@yahoo.co.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
国立病院機構災害医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 13 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029348
