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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028386
Receipt No. 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

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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
Email 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
Email m-uchi@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032494

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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