UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034199
Receipt number R000038986
Scientific Title A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder
Date of disclosure of the study information 2018/09/19
Last modified on 2020/03/23 10:11:00

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Acronym

A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Scientific Title

A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Scientific Title:Acronym

A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Region

Japan


Condition

Condition

Corneal epithelial disorder

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of SJP-0035 compared to placebo dosed four times daily for 28 days in patients with corneal epithelial disorder and to find an optimal dose for clinical use

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in corneal fluorescein staining from the baseline of treatment at week 5

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One drop of SJP-0035 is instilled four times daily for 28 days.

Interventions/Control_2

One drop of SJP-0035 is instilled four times daily for 28 days.

Interventions/Control_3

One drop of placebo is instilled four times daily for 28 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

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)Male or female outpatients, 20 years of age or older
3)Patients with corneal epithelial disorders caused by Sjogren syndrome, tear dysfunction or diabetic keratopathy
4)Patients with moderate to severe corneal epithelial disorders in the central zone
5)Patients with blurred vision caused by corneal epithelial disorders

Key exclusion criteria

1)Patients with prior ocular instillation of SJP-0035
2)Patients who currently have punctal occlusions inserted or with surgical punctal closure
3)Patients with best corrected visual acuity =< 0.2
4)Patients with corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea
5)Patients with any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures
6)Patients with removal of punctal occlusions within the last 14 days
7)Patients with previous intraocular surgery within the last 28 days
8)Patients with previous refractive surgery within the last 180 days
9)Patients with use of any ocular medication within the last 28 days
10)Patients who need the treatment for possibly improving ocular symptoms such as eye wash, lid hygiene, warm compress or massage, in either eye within 14 days prior to the first dose of study drug through the duration of the study
11)Patients who has a known hypersensitivity or significant adverse drug reaction to PPAR agonists, related compounds or any ingredients of drugs used in this study
12)Presence of a cancer or a serious systemic disease

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chie Sotozono

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code


Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5577

Email

csotozon@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Sekiya

Organization

Senju Pharmaceutical Co.,Ltd.

Division name

Clinical Development

Zip code


Address

3-1-9, Kawara-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9605

Homepage URL


Email

t-sekiya@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


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

2018 Year 09 Month 19 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

2018 Year 07 Month 04 Day

Date of IRB

2018 Year 09 Month 10 Day

Anticipated trial start date

2018 Year 09 Month 19 Day

Last follow-up date

2019 Year 03 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 19 Day

Last modified on

2020 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name