UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027167 |
|---|---|
| Receipt number | R000031132 |
| Scientific Title | Availability of DR-1 on the assessment of tear film on the ocular surface |
| Date of disclosure of the study information | 2017/04/27 |
| Last modified on | 2017/11/17 16:39:57 |
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Basic information
Public title
Availability of DR-1 on the assessment of tear film on the ocular surface
Acronym
DR-1 on the assessment of tear film
Scientific Title
Availability of DR-1 on the assessment of tear film on the ocular surface
Scientific Title:Acronym
DR-1 on the assessment of tear film
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficiency of DR-1 to dry eye in the eyes with soft contact lens
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DR-1
Key secondary outcomes
Dry eye questionnaire
Tear break up time
Functional visual acuity
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
soft contact lens users
Key exclusion criteria
patients undergone ophthalmic surgery within 6 months
patients with lacrimal punctal plugs
patients with severe systemic diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minako Kaido |
Organization
Wada Eye Clinic
Division name
ophthalmology
Zip code
Address
Houjyou 2578 Tateyama-shi Chiba japan
TEL
0470-22-6311
fwiw1193@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minako Kaido |
Organization
Wada Eye Clinic
Division name
ophthalmology
Zip code
Address
Houjyou 2578 Tateyama-shi Chiba japan
TEL
0470-22-6311
Homepage URL
fwiw1193@mb.infoweb.ne.jp
Sponsor or person
Institute
Wada Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 04 | Month | 27 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 03 | Day |
Other
Other related information
not applicable
Management information
Registered date
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031132
| 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 |
