UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of SJP-0118 in healthy elderly (once a daily and twice a daily dosing study)
Title of the study (Brief title)	Clinical efficacy study of SJP-0118
Region	Japan

Condition
Condition	Healthy Elderly
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to determine the safety and the effect on external ocular surface bacterial flora of SJP-0118 in healthy elderly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Adverse event) will be assessed from day 1 to 4 and eradiation rates at day 4
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	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SJP-0118 is instilled by once a day for 4 days.
Interventions/Control_2	SJP-0118 is instilled by twice on the first three days and once a day on the day 4.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Signature of the subject on the Informed Consent Form. 2) Male or female subject who is at least 65year of age.
Key exclusion criteria	1) Abnormal findings with ocular biomicroscopy in either eye. 2) History of recurrent corneal erosion syndrome. 3) Any corneal abnormalities (except for physiological superficial punctate keratitis) in either eye. 4) Subject with best-corrected visual acuity equal to or less than 0.3 in either eye. 5) History of ocular injury within the past 90 days. 6) Willing to use contact lens or punctual plug during the study. 7) Ocular surgery within the past 90 days in either eye. 8) Subject need to use any drugs (including over the counter drugs) within past 1 week and during the study. 9) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders. 10) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications. 11) Participation in any other clinical study within past 90 days. Willing to participate in other clinical study during the study. 12) 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 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 20 Day
Anticipated trial start date	2015 Year 12 Month 21 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 20 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=R000022965