UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024041 |
|---|---|
| Receipt number | R000027687 |
| Scientific Title | Evaluation to the effects on the tear film lipid layer of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with Meibomian gland dysfunction. |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2018/03/16 09:17:58 |
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Basic information
Public title
Evaluation to the effects on the tear film lipid layer of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with Meibomian gland dysfunction.
Acronym
Effects of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with MGD.
Scientific Title
Evaluation to the effects on the tear film lipid layer of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with Meibomian gland dysfunction.
Scientific Title:Acronym
Effects of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with MGD.
Region
| Japan |
Condition
Condition
Dry eye patients with Meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of 3% Diquafosol Sodium ophthalmic solution to the dry eye with MGD
Comparison to consider the artificial tears the change over time in the tear film lipid layer thickness by 3% Diquafosol Sodium ophthalmic solution
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tear film lipid layer thickness
Tear film meniscus
Symptoms
Superficial punctate keratopathy
Tear film breakup time
Meibography meiboscore
Tear volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3% Diquafosol sodium ophthalmic solution
Interventions/Control_2
Soft Santear
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Over 20years old
Male and Female
Patients diagnosed as dry eye by 2006 diagnostic criteria for dry eye with Superficial punctate keratopathy.
Patients with MGD
Tear film lipid layer thickness is less than 75nm by LipiView
Key exclusion criteria
High degree of eye damage due to Stevens-Johnson syndrome, or ocular pemphigoid, etc.
Infection of keratoconjunctival or eyelid.
Obvious ocular surface or eyelid disease (eyelid congenital anomaly, entropion, ectropion)
There is an allergic disease in inspection time
Daily wear of contact lenses (average four days a week or more of wearing is considered every day. Wear history, from time to time the wearer is inspection day remove)
Patients with surgical history in the internal eye within 3 months prior to initiation of the clinical research.
History of systemic disease or eye disease can affect the tear production and function
Punctal plug insertion
Lipid hypersecretion from the meibomian glands
Patient even if the pressure on the eyelid in Arita Meibomian Gland
Target sample size
100
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
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Itoh Clinic
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（Itoh clinic）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 20 | 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 | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | 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 | 09 | Month | 13 | 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=R000027687
| 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 |
