UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of A0001 for Anterior Capsule Staining: Phase III Investigator-initiated Multicenter Clinical Trial
Title of the study (Brief title)	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	Tatsuro Ishibashi
Organization	Kyushu University Hospital
Division name	Director
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	Makiko Uchiyama
Organization	Kyushu University Hospital
Division name	Center for Clinical and Translational Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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