UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054378 |
|---|---|
| Receipt number | R000062110 |
| Scientific Title | Tolerability of Diquas LX on tear film and meibomian glands findings |
| Date of disclosure of the study information | 2024/05/12 |
| Last modified on | 2024/05/12 22:17:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Tolerability of Diquas LX on tear film and meibomian glands findings
Acronym
Tolerability of Diquas LX on objective findings
Scientific Title
Tolerability of Diquas LX on tear film and meibomian glands findings
Scientific Title:Acronym
Tolerability of Diquas LX on objective findings
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-acting diquafosol (DQS) ophthalmic solution (DQS-LX) has significant advantages in terms of adherence due to reduced frequency of eye drops. However, some patients prefer conventional DQS. To clarify the characteristics of cases preferring each ophthalmic solution, dry eye (DE) and meibomian gland (MG) findings were retrospectively investigated.
Basic objectives2
Others
Basic objectives -Others
We examined objective parameters for tolerability of DQS-LX.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
For patients who switched to DQS-LX after 3 or more months of continuous DQS eye drops and wished to return to DQS-LX within 1 month, the test items were measured in the meiboscore at the time of DQS-LX switch and compared to those who did not wish to do so.
Key secondary outcomes
For patients who switched to DQS-LX after more than 3 months of continuous DQS eye drops and wished to return to DQS-LX within 1 month, the following test items were measured at the time of DQS-LX switch: subjective symptoms (SPEED), tear film stability (BUT), tear film meniscus (TMH), corneal and conjunctival epithelial staining (CFS), conjunctival hyperemia/papule, Plugging, Vascularity, meibum grade, and Schirmer values were measured and compared to those not desired.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects were DE patients who had been on DQS eye drops at Itoh Clinic for more than 3 months and switched to DQS-LX, who requested to switch back to the original DQS within 1 month, and those who continued to use DQS as is.
Key exclusion criteria
Those that have not had DQS eye drops for more than 3 months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Reiko
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itoh Clinic
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama, Japan
Tel
0486865588
ritoh@za2.so-net.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
IRIN2023-0909
Org. issuing International ID_1
Itoh Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
341
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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2024 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062110
