UMIN-CTR Clinical Trial

Public title

A phase III placebo-controlled comparative study of SJP-0118 in patients with bacterial conjunctivitis

Acronym

A placebo-controlled comparative study in patients with bacterial conjunctivitis

Scientific Title

A phase III placebo-controlled comparative study of SJP-0118 in patients with bacterial conjunctivitis

Scientific Title:Acronym

A placebo-controlled comparative study in patients with bacterial conjunctivitis

Region

Japan

Condition

bacterial conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of 1% SJP-0118 compared to placebo instilled twice-daily for 2 days, followed by once-daily for 5 days in patients with bacterial conjunctivitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One drop of 1% SJP-0118 is instilled twice-daily (in the morning and in the evening) for 2 days, followed by once-daily (in the morning) for 5 days.

Interventions/Control_2

One drop of placebo is instilled twice-daily (in the morning and in the evening) for 2 days, followed by once-daily (in the morning) for 5 days.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

7

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Written informed consent obtained from the subject (or the subject's legally acceptable representative who ensures his/her maximum benefit when the he/she is under 20 years old) after adequate explanation on participating the study
2) Male or female outpatient aged 7 years or older at the time of obtaining consent
3) Diagnosis of bacterial conjunctivitis
4) Each score of eye discharge and hyperaemia >=1

Key exclusion criteria

1) Possible ocular infection other than the trial indication
2) Possible allergic conjunctivitis or onset of its symptom during the study
3) Any history of recurrent erosion of cornea
4) Corneal findings of "+" or worse
5) Corrected visual acuity =<0.2
6) Instillation of any ophthalmic solution within 2 hours prior to the examinations on the start day of treatment
7) Systemic use, ocular instillation or topical dermal application around eyes of any antibiotic or synthetic antibacterial agent within one week prior to the start of treatment
8) Systemic use of corticosteroids or ocular instillation of corticosteroids or NSAIDs within one week prior to the start of treatment
9) Ocular surgery within 90 days prior to the start of treatment
10) 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
11) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study, azithromycin or other macrolide antibiotics
12) Past ocular instillation of azithromycin

Target sample size

640

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 683-8503

TEL

0859-33-1111

Email

yoinoue@grape.med.tottori-u.ac.jp

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

Email

y-nakamura@senju.co.jp

Institute

Senju Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

Senju Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

04

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

03

Month

06

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

04

Month

18

Day

Last modified on

2018

Year

10

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030980