UMIN-CTR Clinical Trial

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