UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase III open clinical study of SJP-0118 in patients who schedule intraocular surgery
Title of the study (Brief title)	An open clinical study in patients who schedule intraocular surgery
Region	Japan

Condition
Condition	Patients who schedule intraocular surgery
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy (preoperative disinfection of bacterial flora in conjunctival sac) and safety of 1% SJP-0118 dosed twice-daily for 3 days prior to the surgery, followed by once-daily on the day of surgery in patients who schedule intraocular surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Preoperative disinfection: the rate of patients who administered the study drug with a negative result in the bacteriological examination on the day of surgery or at the discontinuation
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	One drop of 1% SJP-0118 is instilled into the operative eye twice-daily (in the morning and in the evening) in the preoperative 3 days and once prior to the surgery on the day of surgery (Day 4).
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	1) Written informed consent obtained after adequate explanation on participating the study 2) Japanese male or female, 20 years of age or older at the time of obtaining consent, irrespective of inpatient or outpatient 3) Scheduled intraocular surgery
Key exclusion criteria	1) Scheduled ocular surgery in the opposite eye to the treated eye during the study period 2) Possible ocular infection in the treated eye judged by clinical findings 3) Any history of recurrent erosion of cornea, particularly corneal ulcer, in the treated eye 4) Corneal findings of "+" or worse in the treated eye 5) Use of any antibiotic or synthetic antibacterial agent one week prior to the start of treatment (systemic, ocular instillation in either eye or topical dermal application around eyes) 6) Any history of ocular surgery in the treated eye within 90 days prior to the start of study treatment 7) Presence of a cancer or a serious systemic disease such as serious hepatic disorder, serious renal disorder, serious cardiovascular disease or serious endocrine system disease 8) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study (e.g. fluorescein, and so on), azithromycin or other macrolide antibiotics 9) Past ocular instillation of azithromycin
Target sample size	150

Research contact person
Name of lead principal investigator	Yoshitsugu Inoue
Organization	Tottori University
Division name	Division of Ophthalmology and Visual Science, Faculty of Medicine
Address	86 Nishi-cho,Yonago-shi,Tottori-ken, Japan
TEL	0859-33-1111
Email	yoinoue@grape.med.tottori-u.ac.jp

Public contact
Name of contact person	Yoshikuni Nakamura
Organization	Senju Pharmaceutical Co.,Ltd.
Division name	Planning & Medical Writing, Clinical Development
Address	3-1-9, Kawara-machi, Chuo-ku, Osaka, Japan
TEL	06-6201-9605
Homepage URL
Email	y-nakamura@senju.co.jp

Sponsor
Institute	Senju Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization	Senju Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 03 Month 17 Day
Last follow-up date
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 03 Month 10 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030417