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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034460
Receipt No. 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 2019/04/13

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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
Email 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
Email fujishima117@gmail.com

Sponsor
Institute Tsurumi University

Institute
Department

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
Email 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 12 Day
Last modified on
2019 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038137

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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