UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026494 |
|---|---|
| Receipt number | R000030417 |
| Scientific Title | A phase III open clinical study of SJP-0118 in patients who schedule intraocular surgery |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2018/03/13 10:36:44 |
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Basic information
Public title
A phase III open clinical study of SJP-0118 in patients who schedule intraocular surgery
Acronym
An open clinical study in patients who schedule intraocular surgery
Scientific Title
A phase III open clinical study of SJP-0118 in patients who schedule intraocular surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Inoue |
Organization
Tottori University
Division name
Division of Ophthalmology and Visual Science, Faculty of Medicine
Zip code
Address
86 Nishi-cho,Yonago-shi,Tottori-ken, Japan
TEL
0859-33-1111
yoinoue@grape.med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikuni Nakamura |
Organization
Senju Pharmaceutical Co.,Ltd.
Division name
Planning & Medical Writing, Clinical Development
Zip code
Address
3-1-9, Kawara-machi, Chuo-ku, Osaka, Japan
TEL
06-6201-9605
Homepage URL
y-nakamura@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030417
