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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026105
Receipt No. 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

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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
Email 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
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center
Department of pulmonology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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