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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039339
Receipt No. R000043804
Scientific Title An observational study to compare users of rebamipide ophthalmic solution with non-users among patients suffering from dacryocystitis with calculus
Date of disclosure of the study information 2020/02/10
Last modified on 2020/05/21

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Basic information
Public title An observational study to compare users of rebamipide ophthalmic solution with non-users among patients suffering from dacryocystitis with calculus
Acronym An observational study to compare users of rebamipide ophthalmic solution with non-users among patients suffering from dacryocystitis with calculus
Scientific Title An observational study to compare users of rebamipide ophthalmic solution with non-users among patients suffering from dacryocystitis with calculus
Scientific Title:Acronym An observational study to compare users of rebamipide ophthalmic solution with non-users among patients suffering from dacryocystitis with calculus
Region
Japan

Condition
Condition dacryocystitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether background factors differ depending on the use of rebamipide ophthalmic solution in patients suffering from dacryocystitis with calculus to explore the cause of calculus related to the product.
Basic objectives2 Others
Basic objectives -Others Exploratory survey of patients' background characteristics
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Gender
Age, Birthdate
Eye to be investigated
The day of onset and type of dacryocystitis-related symptoms in the eye to be investigated (lacrimation, eye discharge, swelling, feeling of calculus, and others)
Treatment, course, and outcome of lacrimal sac calculi in the eye to be investigated
Use of rebamipide ophthalmic solution
Medication (name of drug, purpose of use, usage and dose, date of the initial administration, date of completion of the administration)
History of punctal plug use
Complications (on eyes or systemic)
History of lacrimal duct obstruction or dacryocystitis, period, and treatment
Habit of smoking, daily number of cigarettes, years of smoking history
Habit of alcohol drinking, type of alcohol, average daily intake
Composition of lacrimal sac calculi in the eye to be investigated (rebamipide, protein, borate, and calcium phosphate)
Bacterial culture and identification
Dacryocystography
Schirmer's test
Corneal fluorescein staining
DEQS (Dry Eye related Quality of life Score)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1) Male or female
2) Inpatients or ambulatory patients
3) Patients who are aged of 20 years or older when giving their consent
4) Patients who completed treatment of dacryocystitis accompanied with lacrimal sac calculi
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1) Patients whose history of rebamipide ophthalmic solution use is unknown (within 2 years after onsent of main symptom caused by the dacryocystitis accompanied with lacrimal sac calculi in the eye to be investigated)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Shiraishi
Organization Ehime University
Division name School of Medicine, Department of Ophthalmology
Zip code 791-0204
Address Shitsukawa, Toon city, Ehime
TEL 089-964-5111
Email shiraia@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Takayama
Organization Soiken, Inc.
Division name Clinical Study Support Division
Zip code 101-0052
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 0332951350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Japanese Society of Lacrimal Passage and Tear Dynamics
Institute
Department

Funding Source
Organization Otsuka 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 Institutional Review Board,Ehime University Hospital
Address Shitsukawa, Toon, Ehime
Tel 089-960-5172
Email rinri@m.ehime-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 10 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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 31 Day
Date of IRB
2019 Year 09 Month 24 Day
Anticipated trial start date
2020 Year 02 Month 17 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Survey of endpoints
Investigators survey endpoints-related information from the medical records. As needed, the medical records in other institutions are investigated.

Reporting of cases (data entry)
Investigators enter required information onto EDC (electric data capture), according to the data entry manual to the EDC developed by the responsible person of the data management. Investigators must complete the reporting (data entry onto the EDC) within 2 months after registration on IWRS.

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2020 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043804

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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