UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027665 |
|---|---|
| Receipt number | R000031692 |
| Scientific Title | changes ocular surface temperature and tear film stability during instillation over soft contact lenses |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2020/03/26 17:17:08 |
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Basic information
Public title
changes ocular surface temperature and tear
film stability during instillation over soft contact lenses
Acronym
Changes ocular surface temperature and tear film stability over SCL
Scientific Title
changes ocular surface temperature and tear
film stability during instillation over soft contact lenses
Scientific Title:Acronym
Changes ocular surface temperature and tear film stability over SCL
Region
| Japan |
Condition
Condition
soft contact lenses wearer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, it is said that there are 14 million contact lens wearers in our country. Wearing contact lenses is known as one of the causes of decreasing tears and inducing eye dryness (dry eye), and there are many wearers who are doing dry eye eye drops from above contact lenses. However, it is still unknown what the state of the ocular surface looks like when instilling eye drops on the contact lens. Therefore, in order to investigate the condition on the contact lens after instillation, we examined the contact lens wearer 's eye drop eye dry eye therapeutic agent "diquasofol sodium" from the contact lens on the eye surface temperature change and tears Examine the liquid dynamics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate sustained effect of diquasofol sodium by ocular surface temperature change
Key secondary outcomes
Evaluate sustained effect of diquasofol sodium by non invasive tear break up time and tear menisucus change
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drop a single drop of diquasofol sodium and evaluate before and after 5, 15, 30 ,60 minutes
after instillation.
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
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
soft contact lenses wearer
Key exclusion criteria
ocular disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Itokawa |
Organization
Toho university medical center
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori Nishi Ota-ku, Tokyo
TEL
03-3761-4151
takashi.itokawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Itokawa |
Organization
Toho university medical center
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori Nishi Ota-ku, Tokyo
TEL
03-3761-4151
Homepage URL
takashi.itokawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university medical center
Institute
Department
Personal name
Funding Source
Organization
Toho university medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031692
| 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 |
