UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034460 |
|---|---|
| Receipt number | R000038137 |
| Scientific Title | The efficacy of talymus ophthalmic suspension in the treatment of ocular autoimmune disease |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2021/04/16 13:42:41 |
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Basic information
Public title
The efficacy of talymus ophthalmic suspension in the treatment of ocular autoimmune disease
Acronym
The efficacy of talymus ophthalmic suspension
Scientific Title
The efficacy of talymus ophthalmic suspension in the treatment of ocular autoimmune disease
Scientific Title:Acronym
The efficacy of talymus ophthalmic suspension
Region
| Japan |
Condition
Condition
scleritis, keratoconjunctivitis, corneal transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic effects of talymus ophthalmic suspension on inflammatory ocular surface diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
itching
Key secondary outcomes
visual acuity, hyperemia, ocular pain, corneal epithelial disorders, corneal edema, chemosis, eyelid swelling, conjunctival papillae, conjunctival follicle, intraocular pressure (IOP), necessity of steroid and/or anti-allergic drug therapy, corneal endothelial cell density
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Talymus Ophthalmic Suspension 0.1%
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
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received a full explanation on the objectives and methods of the study, expected effects and adverse drug reactions, respect for the privacy, recompense and compensation, and who themselves or their legal representatives voluntarily provided consent for study participation.
Key exclusion criteria
Subjects who doctors consider ineligible for enrollment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fujishima |
Organization
Tsurumi University
Division name
Faculty of Dentistry
Zip code
2308501
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL
0455808599
fujishima117@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fujishima |
Organization
Tsurumi University
Division name
Faculty of Dentistry
Zip code
2308501
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL
0455808599
Homepage URL
fujishima117@gmail.com
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
Tel
0455808599
fujishima117@gmail.com
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 | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30639466
Number of participants that the trial has enrolled
30
Results
The total score of the 10 clinical signs significantly decreased from baseline 2 weeks after initiating tacrolimus eye drop treatment, except at 2 months. Treatment was gradually tapered, with increasing intervals between applications. Additional medications were required to provide relief in 18 patients during follow-up. No patient discontinued treatment due to adverse drug effects. Herpes keratitis was observed in 3 cases during follow-up. However, these cases were completely controlled.
Results date posted
| 2019 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038137
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
