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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018481
Receipt No. R000021364
Scientific Title Phase III study of Efficacy and Safety of SJP-0118 compared to Vehicle and Levofloxacin in the treatment of bacterial conjunctivitis.
Date of disclosure of the study information 2015/08/25
Last modified on 2016/07/28

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Basic information
Public title Phase III study of Efficacy and Safety of SJP-0118 compared to Vehicle and Levofloxacin in the treatment of bacterial conjunctivitis.
Acronym Efficacy and Safety of SJP-0118 compared to Vehicle and Levofloxacin in the treatment of bacterial conjunctivitis.
Scientific Title Phase III study of Efficacy and Safety of SJP-0118 compared to Vehicle and Levofloxacin in the treatment of bacterial conjunctivitis.
Scientific Title:Acronym Efficacy and Safety of SJP-0118 compared to Vehicle and Levofloxacin in the treatment of bacterial conjunctivitis.
Region
Japan

Condition
Condition Bacterial conjunctivitis
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 compared to Vehicle and Levofloxacin in the treatment of 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 Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
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 5 days.
Interventions/Control_2 Vehicle 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 5 days.
Interventions/Control_3 Levofloxacin is instilled by three times daily for 7 days.
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
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 conjunctivitis and exhibit conjunctival discharge and redness with minimum score of 1.
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 500

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
Email 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 Regulatory Affairs & Medical Writing, Clinical Development
Zip code
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

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
Email

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 08 Month 25 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
2015 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 25 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
2015 Year 07 Month 29 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/ctr_e/ctr_view.cgi?recptno=R000021364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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