UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005340 |
|---|---|
| Receipt number | R000006347 |
| Scientific Title | Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops. |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2013/04/02 11:18:57 |
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Basic information
Public title
Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Acronym
Evaluation of the changes of tears by lipid-containing commercial eye drops.
Scientific Title
Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Scientific Title:Acronym
Evaluation of the changes of tears by lipid-containing commercial eye drops.
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Tear film breakup time, corneal and conjunctival epithelial damage score, tear meniscus radius, Schirmer test(I), spreading velocity of tear film lipid layer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Instillation (Systane® Balance )
Interventions/Control_2
Instillation (Dry Aid® EX)
Interventions/Control_3
Instillation (Soft Santear®)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Normal subject (20 persons) without following 1)-4)
2. Aqueous tear deficient dry eye patients and Short BUT type dry eye patients (30 persons).
3. Aqueous tear deficient dry eye patients with following 1),2) and 4)
4. Short BUT type dry eye patients with following 1) and 3) who have not been responsible for conventional instillation treatment.
1) Symptoms (Visual disturbance, Discomfort)
2) Schirmer test (I) <= 5mm
3) Tear film breakup time <= 5 seconds
4) Positive vital dye staining of cornea and conjunctiva (Fluorescein, Lissamine green)(more than 3, maximum=9)
Key exclusion criteria
Anyone who is considered to be inappropriate for this study
(ex. Any allergic history to Systane Balance, Dry Aid® EX and SoftSantear®, women who are under pregnant or lactation period)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiko Yokoi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 kajiicho kawaramachidori hirokouji agaru kamigyoku Kyoto city
TEL
075-251-5575
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiko Yokoi, Takahiro Kurose |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 kajiicho kawaramachidori hirokouji agaru kamigyoku Kyoto city
TEL
075-251-5578
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006347
| 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 |
