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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024041
Receipt No. 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

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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
Email 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
Email ritoh@za2.so-net.ne.jp

Sponsor
Institute Itoh Clinic
Department of Ophthalmology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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