UMIN-CTR 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 |
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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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000038986
