UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024310 |
|---|---|
| Receipt number | R000027999 |
| Scientific Title | Study on the binding of constituents in eye-drops to aqueous humor albumin and the effect of drug efficacy |
| Date of disclosure of the study information | 2016/10/06 |
| Last modified on | 2021/11/10 23:06:22 |
* 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
Study on the binding of constituents in eye-drops to aqueous humor albumin and the effect of drug efficacy
Acronym
Study on the binding of drug to proteins in aqueous humor
Scientific Title
Study on the binding of constituents in eye-drops to aqueous humor albumin and the effect of drug efficacy
Scientific Title:Acronym
Study on the binding of drug to proteins in aqueous humor
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is the purpose of this study to elucidate the extent of albumin binding of diclofenac sodium in aqueous humor and the relation to the environment.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The binding affinity of diclofenac sodium to albumin in aqueous humor of each patient.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of aqueous humor and blood samples from subjects with treatment with glucose
Interventions/Control_2
Collection of aqueous humor and blood samples from subjects without treatment with glucose
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. The patient is twenty or over when the informed consent was gotten.
2. The patient who received satisfactory explanations and understood truly and the patient who was agreed to the informed consent by his own free will.
Key exclusion criteria
1. The patient who has lack of capacity to give informed consent owing to some mental disorder.
2. The patient who needs a legal guardian.
3. The diabetic patient with HbA1c equal to or greater than 6.5 %.
4. The patient who is not applicable to cataract operation.
5. The case of cataract except for senile cataract.
6. The others the patient who the person responsible for study judged to be unsuitable.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Ikeda |
Organization
University of Miyazaki Hospital
Division name
Department of Pharmacy
Zip code
8891692
Address
5200 Kiyotake-cho Kihara, Miyazaki city, Miyazaki 889-1692
TEL
0985-85-9429
ikeda@cc.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Saya |
| Middle name | |
| Last name | Ishii |
Organization
University of Myazaki Hospital
Division name
Department of Pharmacy
Zip code
8891692
Address
5200 Kiyotake-cho Kihara, Miyazaki
TEL
0985-85-9429
Homepage URL
sayaishii38@gmail.com
Sponsor or person
Institute
University of Miyazaki Hospital
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
University of Miyazaki Hospital, clinical research support center
Address
5200 Kiyotake-cho Kihara, Miyazaki-city, Miyazaki 889-1692
Tel
0985-85-9403
inorinri@med.miyazaki-u.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
| 2016 | Year | 10 | Month | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027999
