UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018481 |
|---|---|
| Receipt number | 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 09:14:08 |
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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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021364
