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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034199
Receipt No. 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 2019/03/25

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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 No longer recruiting
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
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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