UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051390 |
|---|---|
| Receipt number | R000058628 |
| Scientific Title | Investigation of the effect of long-acting diquafosol sodium ophthalmic solution on the ocular surface and its usability |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/08 12:34:25 |
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Basic information
Public title
Investigation of the effect of long-acting diquafosol sodium ophthalmic solution on the ocular surface and its usability
Acronym
Investigation of the effect of long-acting diquafosol sodium ophthalmic solution
Scientific Title
Investigation of the effect of long-acting diquafosol sodium ophthalmic solution on the ocular surface and its usability
Scientific Title:Acronym
Investigation of the effect of long-acting diquafosol sodium ophthalmic solution
Region
| Japan |
Condition
Condition
Dry eye (DE)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a long-acting diquafosol ophthalmic solution (DIQUAS LX; DQS-LX), on Ocular surface, usability, and tolerability in dry eye (DE).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical findings and usability of ophthalmic solution
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
Long-acting diquafosol 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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with dry eye using diquafosol ophthalmic solution
Key exclusion criteria
the presence of ocular surgery and trauma within the last 6 months, permanent structural damage due to ocular trauma, receiving pressure-lowering agents for the treatment of glaucoma and current contact lens
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada Eye Clinic
Division name
Ophthalmology
Zip code
294-0045
Address
Houjyou 2578-27, Tateyama-shi, Chiba
TEL
0335358525
tomoulton777@ff.em-net.ne.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada Eye Clinic
Division name
Ophthalmology
Zip code
294-0045
Address
Houjyou 2578-27, Tateyama-shi, Chiba
TEL
0335358525
Homepage URL
tomoulton777@ff.em-net.ne.jp
Sponsor or person
Institute
Wada Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itoh Clinic
Address
Minaminakano 626-11, Ooaza, minoma-ku, Saitama-shi, Saitama
Tel
0487920677
arita.reiko@gmail.com
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 | 08 | Month | 07 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058628
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058628
