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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018510
Receipt No. R000021425
Scientific Title Evaluation of efficacy of diquafosol sodium eyedrop
Date of disclosure of the study information 2015/08/01
Last modified on 2017/07/24

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Basic information
Public title Evaluation of efficacy of diquafosol sodium eyedrop
Acronym Evaluation of efficacy of diquafosol sodium eyedrop
Scientific Title Evaluation of efficacy of diquafosol sodium eyedrop
Scientific Title:Acronym Evaluation of efficacy of diquafosol sodium eyedrop
Region
Japan

Condition
Condition Meibomian gland dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of diquafosol sodium ophthalmic solution for the Dry Eye patients with MGD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Symptoms
2. Slit lamp
3. Tear film breakup time
4. Meibography
5.Tear volume , Tear thickness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diquafosol sodium ophthalmic solution
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Over 20years old
2. Male and Female
3. Patients diagnosed as dry eye
4. Patients with MGD
Key exclusion criteria 1. atients who use dry eye or MGD treatment within 2 weeks before a study starts.
2. Patient who have a previous history of treatment intended to become obstructed lacrimal puncta.
3. Patients who need to use eyedrops other than test drugs during a study.
4. Patients who have anatomically and functionally abnormal eyelid.
5. Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to initiation of the clinical research.
6. Patients who have a previous allergy to drugs that they use during a study.
7. Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study
Target sample size 30

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 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL 03-3295-0911
Email 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 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL 03-3295-0911
Homepage URL
Email amanoshiro1126@gmail.com

Sponsor
Institute Inouye Eye Hospital
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
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 医療法人社団 済安堂 お茶の水・井上眼科クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 01 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
2015 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 22 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
2015 Year 07 Month 31 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021425

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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