UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031169 |
|---|---|
| Receipt number | R000035369 |
| Scientific Title | Evaluation of sense of commercial eye drops for contact lens wearers |
| Date of disclosure of the study information | 2018/02/07 |
| Last modified on | 2018/03/07 18:11:10 |
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Basic information
Public title
Evaluation of sense of commercial eye drops for contact lens wearers
Acronym
Evaluation of sense of commercial eye drops for contact lens wearers
Scientific Title
Evaluation of sense of commercial eye drops for contact lens wearers
Scientific Title:Acronym
Evaluation of sense of commercial eye drops for contact lens wearers
Region
| Japan |
Condition
Condition
Contact lens wearers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the refreshing feeling of commercial eye drops for contact lens wearers which have cooling sensation.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Four eye drops will be tested. Instill one drop each to both eyes with wearing contact lenses, and then answer to the questionnaire. (Take interval of 30 minutes for each eye drops)
Key secondary outcomes
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
Four eye drops will be tested for one time each.
(Instill one drop each to both eyes, and test another eye drops after 30 minutes in the same way.)
a) Eye drops P: New Mytear CL Cool - a
b) Eye drops Q: New Mytear CL Cool Hi-a
c) Eye Drops R: New Mytear CL Cool Ice Crush
d) Eye drops S: First Mytear CL-B
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who wearing contact lenses.
2) Those who have no disease in the eyes.
3) Those who purchase commercial cool type eye drops for contact lens wearers by themselves.
Key exclusion criteria
1) Those who are not wearing contact lenses.
2) Those who have not purchased commercial eye drops.
3) Those who mainly use non-cool type eye drops for contact lens wearers.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitosh Adachi |
Organization
Senju Pharmaceutical Co., Ltd
Division name
Nonprescription Drug Division
Zip code
Address
2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL
06-6201-9615
hitoshi-adachi@senju.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyoshi Soma |
Organization
Senju Pharmaceutical Co., Ltd
Division name
Nonprescription Drug Division Marketing Third Group
Zip code
Address
2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL
06-6201-9615
Homepage URL
n-souma@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Senju 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
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
| 2018 | Year | 02 | Month | 07 | 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
| 2018 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035369
| Research Plan | |
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| 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 |
