UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028386 |
|---|---|
| Receipt number | R000032494 |
| Scientific Title | Efficacy and Safety of A0001 for Anterior Capsule Staining: Phase III Investigator-initiated Multicenter Clinical Trial |
| Date of disclosure of the study information | 2017/08/07 |
| Last modified on | 2018/07/27 09:32:48 |
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Basic information
Public title
Efficacy and Safety of A0001 for Anterior Capsule Staining: Phase III Investigator-initiated Multicenter Clinical Trial
Acronym
Efficacy and Safety of A0001 for Anterior Capsule Staining
Scientific Title
Efficacy and Safety of A0001 for Anterior Capsule Staining: Phase III Investigator-initiated Multicenter Clinical Trial
Scientific Title:Acronym
Efficacy and Safety of A0001 for Anterior Capsule Staining
Region
| Japan |
Condition
Condition
Refractory cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Visualization of the anterior capsule using A0001 during cataract surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Central evaluation of the efficacy of A0001 administered to anterior camber for visualization of the anterior capsule during cataract surgery.
Key secondary outcomes
-Evaluation of degree of visualization and evaluation of ease of operation by surgeon.
-Evaluation of the safety of A0001 based on data of adverse effects, side effects, ophthalmological examinations.
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Brilliant Blue G250
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
There are indications for cataract surgery for one eye or both eyes, and cataract with severe cortical cataract, mature cataract, hyperzagmus cataract, cataract with corneal opacity, cataract with vitreous opacity, etc. Cataract in which it is difficult to see the anterior capsule of the lens in normal cataract surgery.
Key exclusion criteria
1) IOL implanted eye.
2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications
3) Had present and past uveitis or glaucoma
4) Those who fall under Grade 3 or Grade 4 in the classification of "Grading for Corneal Endothelial Damage (2014) "prescribed by the Japan Corneal Society. However, cases where it is difficult to measure the number of corneal endothelial cells by corneal clouding or the like can be incorporated.
5) Patient of Bullous keratopathy
6) Has a history of drug hypersensitivity reactions for mydriatic, antibacterial eyedrops or local anesthetic.
7) Has a history of drug or alcohol abuse
8) Had taken this clinical trial
9) Those who participated in other clinical trials or clinical studies within 30 days before consent acquisition and received medication, or those planning to participate in other trials during this trial
8) Is deemed unsuitable for this trial by PI or SI
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishibashi |
Organization
Kyushu University Hospital
Division name
Director
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5648
ishi@eye.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Uchiyama |
Organization
Kyushu University Hospital
Division name
Center for Clinical and Translational Research
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-6291
Homepage URL
m-uchi@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
杏林大学医学部付属病院、大阪大学医学部附属病院、滋賀医科大学附属病院、奈良県立医科大学附属病院、山口大学医学部附属病院、大分大学医学部附属病院、大島眼科病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 07 | 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
| 2017 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032494
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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