UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030205 |
|---|---|
| Receipt number | R000034503 |
| Scientific Title | Investigation for non-infectious keratitis in contact lens users. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2020/06/03 10:46:38 |
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Basic information
Public title
Investigation for non-infectious keratitis in contact lens users.
Acronym
Investigation for non-infectious keratitis
Scientific Title
Investigation for non-infectious keratitis in contact lens users.
Scientific Title:Acronym
Investigation for non-infectious keratitis
Region
| Japan |
Condition
Condition
non-infectious keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the conditions of non-infectious keratitis in contact lens users
Basic objectives2
Others
Basic objectives -Others
Clinical survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical appearance, the types of contact lenses, purchase method, confocal observation
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Contact lens usage
(2) Ocular pain, foreign body sensation, conjunctival injection
Key exclusion criteria
(1) Clinical sign with infectious keratitis
(2) Patients who cannot cooperate to this study
(3) Patients whom doctors judge as non-adequate subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Morishige |
Organization
Ohshima Eye Hospital
Division name
Division of Cornea and Ocular Surface
Zip code
812-0036
Address
11-8 Kamigofukumachi, Hakata-Ku, Fukuoka, Fukuoka 812-0036, Japan
TEL
092-281-3020
morishig@corneajp.com
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Morishige |
Organization
Ohshima Eye Hospital
Division name
Ophthalmology
Zip code
8120036
Address
11-8 Kamigofukumachi, Hakata-Ku, Fukuoka, Fukuoka 812-0036, Japan
TEL
092-281-3020
Homepage URL
morishig@corneajp.com
Sponsor or person
Institute
Ohshima Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Ohshima Eye Hospital
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
Internal Review Board, Ohshima Eye Hospital
Address
11-8 Kamigofukumachi, Hakata-Ku, Fukuoka
Tel
092-281-3020
morishig@corneajp.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
| 2017 | Year | 12 | Month | 01 | 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
30
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 | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
collect clinical features and confocal microscopic findings
Management information
Registered date
| 2017 | Year | 12 | Month | 01 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
