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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021884
Receipt No. R000025235
Scientific Title Clinical Research of Diquas ophthalmic solution 3% on corneal epithelial barrier function in dry eye
Date of disclosure of the study information 2016/04/12
Last modified on 2018/06/21

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Basic information
Public title Clinical Research of Diquas ophthalmic solution 3% on corneal epithelial barrier function in dry eye
Acronym Clinical Research of Corneal epithelial barrier function
Scientific Title Clinical Research of Diquas ophthalmic solution 3% on corneal epithelial barrier function in dry eye
Scientific Title:Acronym Clinical Research of Corneal epithelial barrier function
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effectiveness of Diquafosol Sodium ophthalmic solution for corneal epithelial barrier function in dry eye
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Corneal epithelial barrier function
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 Patients who were diagnosed as definite and probable dry eye, and corneal and conjunctival staining 1 point and over [9 point scale].
Key exclusion criteria Patients with a history of allergy to fluorescein
Patients who have allergic conjunctivitis, and have possibilities to get worse during study phase.
Experience in using Diquas ophthalmic solution 3%.
The investigator or subinvestigator has judged that the patient is ineligible as study subject.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Yamada
Organization Kyorin university School of Medicine
Division name Department of ophthalmology
Zip code
Address 6-20-2 Shinkawa,Mitaka,Tokyo
TEL 0422-47-5511
Email yamada@eye-center.org

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Yamada
Organization Kyorin university School of Medicine
Division name Department of ophthalmology
Zip code
Address 6-20-2 Shinkawa,Mitaka,Tokyo
TEL 0422-47-5511
Homepage URL
Email yamada@eye-center.org

Sponsor
Institute Collaborative joint clinical research organized with Kyorin university School of Medicine and 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 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 杏林大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 12 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 Terminated
Date of protocol fixation
2015 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 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 04 Month 12 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025235

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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