UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021884 |
|---|---|
| Receipt number | 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 15:16:16 |
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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
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
yamada@eye-center.org
Sponsor or person
Institute
Collaborative joint clinical research organized with Kyorin university School of Medicine and Santen Pharmaceutical Co., Ltd.
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025235
