UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038986