UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase III placebo-controlled comparative study of SJP-0118 in patients with bacterial conjunctivitis
Title of the study (Brief title)	A placebo-controlled comparative study in patients with bacterial conjunctivitis
Region	Japan

Condition
Condition	bacterial conjunctivitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of 1% SJP-0118 compared to placebo instilled twice-daily for 2 days, followed by once-daily for 5 days in patients with bacterial conjunctivitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical resolution will be assessed at day 3 and 7 according to Guidelines for the Clinical Trials of Antibacterial Ophthalmic Solution [Nippon Ganka Gakkai Zasshi. 2015;119(4)273-86].
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One drop of 1% SJP-0118 is instilled twice-daily (in the morning and in the evening) for 2 days, followed by once-daily (in the morning) for 5 days.
Interventions/Control_2	One drop of placebo is instilled twice-daily (in the morning and in the evening) for 2 days, followed by once-daily (in the morning) for 5 days.
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	7 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written informed consent obtained from the subject (or the subject's legally acceptable representative who ensures his/her maximum benefit when the he/she is under 20 years old) after adequate explanation on participating the study 2) Male or female outpatient aged 7 years or older at the time of obtaining consent 3) Diagnosis of bacterial conjunctivitis 4) Each score of eye discharge and hyperaemia >=1
Key exclusion criteria	1) Possible ocular infection other than the trial indication 2) Possible allergic conjunctivitis or onset of its symptom during the study 3) Any history of recurrent erosion of cornea 4) Corneal findings of "+" or worse 5) Corrected visual acuity =<0.2 6) Instillation of any ophthalmic solution within 2 hours prior to the examinations on the start day of treatment 7) Systemic use, ocular instillation or topical dermal application around eyes of any antibiotic or synthetic antibacterial agent within one week prior to the start of treatment 8) Systemic use of corticosteroids or ocular instillation of corticosteroids or NSAIDs within one week prior to the start of treatment 9) Ocular surgery within 90 days prior to the start of treatment 10) 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 11) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study, azithromycin or other macrolide antibiotics 12) Past ocular instillation of azithromycin
Target sample size	640

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 683-8503
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 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 05 Month 15 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 04 Month 18 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030980