UMIN-CTR Clinical Trial

Public title

Phase III study of Efficacy and Safety of SJP-0118 in bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.

Acronym

Clinical study of SJP-0118 in extraocular bacterial infections.

Scientific Title

Phase III study of Efficacy and Safety of SJP-0118 in bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.

Scientific Title:Acronym

Clinical study of SJP-0118 in extraocular bacterial infections.

Region

Japan

Condition

acterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to determine the efficacy and safety of SJP-0118 in the treatment of bacterial extraocular infections.

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, 7 and 14 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

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

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 12 days.

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

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 blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.

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

45

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

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

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

2015

Year

11

Month

09

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

2015

Year

08

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

09

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=R000022755