UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022744 |
|---|---|
| Receipt number | R000026205 |
| Scientific Title | Efficacy of Systane Balance eye drop on tear lipid layer thickness with dry eye patients accompanied with meibomian gland dysfunction |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2018/03/16 09:20:03 |
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Basic information
Public title
Efficacy of Systane Balance eye drop on tear lipid layer thickness with dry eye patients accompanied with meibomian gland dysfunction
Acronym
Efficacy of Systane Balance on lipid layer with meibomian gland dysfunction
Scientific Title
Efficacy of Systane Balance eye drop on tear lipid layer thickness with dry eye patients accompanied with meibomian gland dysfunction
Scientific Title:Acronym
Efficacy of Systane Balance on lipid layer with meibomian gland dysfunction
Region
| Japan |
Condition
Condition
Dry eye accompanied with meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of Sytaine Balance onto the lipid layer thickness, followed by tear film stability with dry eye patients
Basic objectives2
Others
Basic objectives -Others
Changes of lipid layer thickness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Lipid layer thickness (pre, 15 min, 30 min, 60 min)
Key secondary outcomes
Symptoms,tear film breakup time, meiboscore, Schirmer test, tear meniscus height, non-invasive breakup time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Systaine Balance eye drop/artificial tears
4 times a day for 28 days
Interventions/Control_2
artificial tears
4 times a day for 28 days
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dry eye accompanied with meibomian gland dysfunction
Key exclusion criteria
Other ocular diseases, the history of ocular surgery within 3 months
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama
TEL
048-686-5588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano, Minuma-Ku, Saitama,
TEL
048-686-5588
Homepage URL
http://www.itoh-clinic.com/
arita.reiko@gmail.com
Sponsor or person
Institute
Itoh Clinic
Department of Ophthalmology
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
伊藤医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | 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
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026205
