UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030246 |
|---|---|
| Receipt number | R000034544 |
| Scientific Title | Investigation of the influence of anti-glaucoma eyedrops on the ocular surface |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2020/06/08 07:58:29 |
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Basic information
Public title
Investigation of the influence of anti-glaucoma eyedrops on the ocular surface
Acronym
The influence of anti-glaucoma eyedrops on the ocular surface
Scientific Title
Investigation of the influence of anti-glaucoma eyedrops on the ocular surface
Scientific Title:Acronym
The influence of anti-glaucoma eyedrops on the ocular surface
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of anti-glaucoma eyedrops on the ocular surface.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of corneal and conjunctival epithelial damage
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Use of anti-glaucoma eyedrops over 3 months.
Key exclusion criteria
1. Ocular surgery including laser therapy within 3 months.
2. History of corneal or conjunctival surgery.
3. History of glaucoma surgery.
4. History of surgery in thelacrimal drainage system.
5. History of contact lens use over 1 year.
6. Use of eyedrops other than anti-glaucoma eyedrops.
7. Existence of inflammatory disease in the anterior segment of the eye.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Amano |
Organization
Inouye Eye Hospital
Division name
Ophthalmology
Zip code
Address
4-3 Kandasurugadai, Chiyoda-ku, Tokyo
TEL
03-3295-0925
amanoshiro1126@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Amano |
Organization
Inouye Eye Hospital
Division name
Ophthalmology
Zip code
Address
4-3 Kandasurugadai, Chiyoda-ku, Tokyo
TEL
03-3295-0925
Homepage URL
amanoshiro1126@gmail.com
Sponsor or person
Institute
Inouye Eye Hospital
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
Miyata Eye Hospital
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
井上眼科病院（東京都）、宮田眼科病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 08 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire, slit-lamp, tear breakup time, tear breakup pattern, meibography, Schirmer test.
Management information
Registered date
| 2017 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034544
| 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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