UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase III study of Efficacy and Safety of SJP-0118 in bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.
Title of the study (Brief title)	Clinical study of SJP-0118 in extraocular bacterial infections.
Region	Japan

Condition
Condition	acterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to determine the efficacy and safety of SJP-0118 in the treatment of bacterial extraocular infections.
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, 7 and 14 according to Guidelines for the Clinical Trials of Antibacterial Ophthalmic Solution [Nippon Ganka Gakkai Zasshi. 2015;119(4)273-86].
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	SJP-0118 is instilled by twice on the first two days (once in the morning and at bedtime) and once a day in the morning for the following 12 days.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Signature of the subject or legally authorized representative on the Informed Consent Form. 2) Male or female subject who is at least 19 year of age. 3) Subjects must have had a clinical diagnosis of bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.
Key exclusion criteria	1) Subjects with suspected fungal, viral, or Acanthamoeba infection. 2) Subjects with suspected allergic conjunctivitis. 3) History of recurrent corneal erosion syndrome. 4) Any corneal epithelial loss, specifically any corneal ulcer (except for superficial punctate keratitis). 5) Subject with best-corrected visual acuity equal to or less than 0.2 in both eyes. 6) Subject need to use concomitant therapy during the study. 7) Use of any antibiotic (systemic, topical or dermally around eyelid) within 1 week of enrollment. 8) Use of any corticosteroid or nonsteroidal antiinflammatory drug (systemic of topical). 9) Ocular surgery within the past 90 days. 10) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders. 11) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications. 12) Willing to use contact lens or punctual plug during the study. 13) Pregnant, nursing, possibility of pregnancy or hope for the pregnancy during the study. 14) Participation in any other clinical study. 15) History of use azithromycin eye drops.
Target sample size	45

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	Regulatory Affairs & Medical Writing, Clinical Development
Address	2-5-8, Hirano-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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2015 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 01 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	2015 Year 11 Month 09 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022755