UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052920 |
|---|---|
| Receipt number | R000060382 |
| Scientific Title | Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops: A Prospective Randomized Non-Blind Intervention Study |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/27 17:57:45 |
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Basic information
Public title
Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops: A Prospective Randomized Non-Blind Intervention Study
Acronym
Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops
Scientific Title
Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops: A Prospective Randomized Non-Blind Intervention Study
Scientific Title:Acronym
Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops
Region
| Japan |
Condition
Condition
Dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare adherence and dry eye treatment efficacy between Diquas LX Eye Drops and Diquas Eye Drops.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence
Key secondary outcomes
Dry eye treatment efficacy
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diquas LX Eye Drops 3% group
Interventions/Control_2
Diquas Eye Drops 3% group
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. Individuals who understand and consent to the consent form.
2. Individuals aged 20 years and older.
Key exclusion criteria
1. Individuals deemed unsuitable as study participants by the principal investigator.
2. Individuals from whom consent could not be obtained.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University
Division name
Graduate School of Medicine, Department of Ophthalmology
Zip code
113-8421
Address
2-1-1 Hongo, Building A, 6th floor, Ophthalmology Department, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tinoma@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University
Division name
Graduate School of Medicine, Department of Ophthalmology
Zip code
113-8421
Address
2-1-1 Hongo, Building A, 6th floor, Ophthalmology Department, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tinoma@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Takenori Inomata
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research and Clinical Trial Center of Juntendo Hospital, Juntendo University School of Medicine.
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo.
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
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
| 2023 | Year | 11 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060382
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
