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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024310
Receipt No. 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 2019/08/28

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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
Email 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
Email sayaishii38@gmail.com

Sponsor
Institute University of Miyazaki Hospital
Institute
Department

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
Email 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 06 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027999

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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