UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049186 |
|---|---|
| Receipt number | R000056025 |
| Scientific Title | Exploratory research of biomarkers for investigational drugs using tear fluid samples |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2025/01/24 11:32:19 |
* 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
Exploratory research of biomarkers for investigational drugs using tear fluid samples
Acronym
Exploratory research of biomarkers for investigational drugs using tear fluid samples
Scientific Title
Exploratory research of biomarkers for investigational drugs using tear fluid samples
Scientific Title:Acronym
Exploratory research of biomarkers for investigational drugs using tear fluid samples
Region
| Asia(except Japan) |
Condition
Condition
Meibomian Gland Dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory research of biomarkers to assess drug response of investigational drug
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression profile (e.g., protein)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who received an investigational drug including placebo at the study sites and consented to the collection and use of tear fluid samples
Key exclusion criteria
Subjects who were unable to calculate the ratio of pre- and post-treatment expression level due to the absence of either sample or subjects who withdrew their consent to opt-out.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kirihara |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Ophthalmology Innovation center
Zip code
5308552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
clinical@santen.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Ophthalmology Innovation center
Zip code
5308552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
Homepage URL
clinical@santen.com
Sponsor or person
Institute
Santen Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Singapore Eye Research Institute
Santen Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Singapore, Japan
Other related organizations
Co-sponsor
Singapore Eye Research Institute
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Santen Pharmaceutical Co. Ltd.
Address
4-20, Ofukacho, Kita-ku, Osaka
Tel
06-4802-9339
clinical@santen.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
| 2022 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
https://iovs.arvojournals.org/article.aspx?articleid=2800337
Publication of results
Published
Result
URL related to results and publications
https://iovs.arvojournals.org/article.aspx?articleid=2800337
Number of participants that the trial has enrolled
29
Results
Protein-protein interaction network analysis showed that mTOR signaling pathway is one of the affected pathways related to MGD and sirolimus treatment. Among them, ATP6V1D showed the greatest decrease by pre-post comparison in the sirolimus-treated group. As for lipids, 12-HETE and 13-HpODE showed a significant increase in tear concentration after treatment compared to pre-treatment with sirolimus.
Results date posted
| 2025 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
MGD
Participant flow
Due to the secondary use of clinical trial data, patient recruitment is not conducted to initiate this study.
Adverse events
Due to the secondary use of clinical trial data, patient recruitment is not conducted to initiate this study. Therefore, no adverse events have occurred.
Outcome measures
Expression profiles of proteins and lipids
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the exploratory research using bio samples which were collected in the completed clinical trial, patient recruitment is not conducted to initiate this study, and the above Anticipated trial start date and Last follow-up date are the same as the protocol confirmation date.
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056025
