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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029333
Receipt No. R000033506
Scientific Title The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Date of disclosure of the study information 2017/10/02
Last modified on 2019/03/26

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Basic information
Public title The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Acronym The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Scientific Title The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Scientific Title:Acronym The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the change of dry eye findings and refraction data
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dry eye examination results, corneal curvature radius, refraction data and adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is 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 Diquafosol Ophthalmic Solution 3%
Interventions/Control_2 Artificial tear Mytear ophthalmic solution
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria To have a plan to be given a cataract surgery.
Key exclusion criteria Being on dry eye medication.
Using contact lens.
Having an infection eye disease.
Having a complication of an eye disease which might have an influence on evaluation of this study.
Having a history of an allergic reaction to the ingredients used in this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Masayo
Middle name
Last name Hashimoto
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Email clinical@santen.co.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Yamada
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9604
Homepage URL
Email clinical@santen.co.jp

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Review Board of Human Rights and Ethics for Clinical Studies Ethics Review Committee
Address 13-2 Ichibancho, Chiyoda-ku, Tokyo
Tel 03-5213-0028
Email info@hurecs.org

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 02 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 20
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
2017 Year 08 Month 04 Day
Date of IRB
2007 Year 08 Month 25 Day
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2018 Year 08 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033506

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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