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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032160
Receipt No. R000033797
Scientific Title Corneal Subbasal Nerve and Maintenance of Ocular Surface
Date of disclosure of the study information 2018/04/09
Last modified on 2019/04/02

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Basic information
Public title Corneal Subbasal Nerve and Maintenance of Ocular Surface
Acronym COSMOS study
Scientific Title Corneal Subbasal Nerve and Maintenance of Ocular Surface
Scientific Title:Acronym COSMOS study
Region
Japan

Condition
Condition Dry eye patients and healthy adults
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to clarify the relationship between the corneal subbasal nerve shape and corneal perception, as well as dry eye symptoms. For that purpose, together with observing and measuring the corneal subbasal nerve shape of dry eye patients and healthy adults using a confocal laser scanning microscopy, we will measure the corneal perception as well as the subjective symptoms that are test items for general dry eye in an ophthalmologic examination of the eye surface, and analyze the perception of the shape of the corneal subbasal nerve, and its relevance to dry eye symptoms. Additionally, we will also search for molecules that are related to changes in nerve density and shape, from the changes in protein in tears and oxidative stress markers found in dry eye.
Basic objectives2 Others
Basic objectives -Others The perception of the shape of the corneal subbasal nerve and its relevance to dry eye symptoms.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The parameters of the corneal subbasal nerve based on the confocal laser scanning microscopy images (Nerve Fibre Length (NFL), Nerve Fibre Density (NFD), Nerve Branch Density (NBD), Nerve Fibre Total Branch Density (TBD), Nerve Fibre Area (NFA), Nerve Fibre Width (NFW)).
Key secondary outcomes a. Parameters related to the neurodegeneration of the corneal subbasal nerves, based on the confocal laser scanning microscopy images (Nerve Fibre Tortuosity (NFT)).
b. Oxidative stress markers in tears (8-Hydroxy-2-deoxyguanosine; 8-OHdG and Propanoyl-lysine; PRL)
c. Comprehensive comparative quantification tear protein, according to iTRAQ
d. Tear film break up time (BUT)
e. Schirmer test I method
f. Corneal conjunctival epithelial disorder fluorescein staining score
g. Corneal perception
h. Subjective symptoms (questionnaires regarding dry eye (The Dry Eye Questionnaire 5; DEQ-5 Japanese version, Ocular Surface Disease Index; OSDI Japanese version), questionnaires regarding Neuropathic Ocular Pain; NOP, visual analog scale regarding dry eye symptoms; VAS)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1)The individual has signed a written consent form in regards to participation in this research.
(2)Persons between the ages of 20 - 64 years old at the time the consent is given (the date the patient agreed to participate in the trial).
<Criteria for Dry Eye Patients>
(3)Persons who have had continual symptoms related to dry eye for one year at the date of consent.
(4)Persons with a score of 6 or more in the questionnaire regarding dry eye (DEQ-5 Japanese version) in the screening test.
(5)Persons with a tear film break-up time (BUT) of 5 seconds or less in the screening test.
<Criteria for Healthy Adults>
(6)Persons with no history of dry eye within one year of the date of consent.
(7)Persons who are not undergoing continual eye drop treatment for other ophthalmological diseases.
(8)Persons with a score of 6 or less in the questionnaire regarding dry eye (DEQ-5 Japanese version) in the screening test.
(9)Those for whom the following criteria applies in the screening test.
a. Tear film break-up time (BUT) >= 8 seconds
b. Corneal conjunctival epithelial disorder fluorescein stain score < 3 points
Key exclusion criteria (1)Persons who have a combination of autoimmune diseases, including atopic dermatitis.
(2)Persons who have Stevens-Johnson syndrome, or advanced ocular disorder due to ocular pemphigus.
(3)Persons with a history of ophthalmic surgery (including corneal refractive surgery (LASIK), punctal plug insertion surgery).
(4)Glaucoma patients (currently undergoing treatment).
(5)Persons with a combination of anterior eye disease, excluding dry eye.
(6)Persons with a combination of infectious disease.
(7)Persons who cannot stop using eye drop medicine (all prescription and marketed drugs, except for artificial tears) and those who anticipate usage, for the period from the screening test to the end of the research.
(8)Persons who cannot stop wearing contact lenses for one week prior to each visit.
(9)Any other persons who are judged to be inappropriate for this research by the physician in charge of implementing this research.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Shimazaki
Organization Tokyo Dental Collage, Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba
TEL 047-322-0151
Email jun@eyebank.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroo Homma
Organization IDD, Inc.
Division name Regulatory Affairs
Zip code
Address Okino Bldg. 201, 2-14-19, Minami Azabu, Minato-ku, Tokyo
TEL 03-3473-0100
Homepage URL
Email cosmos@idd-inc.co.jp

Sponsor
Institute COSMOS study Group
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 医療法人社団慶幸会 ピーワンクリニック

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 09 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 59
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
2017 Year 10 Month 05 Day
Date of IRB
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 10 Month 30 Day
Last follow-up date
2017 Year 11 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Partial screening, intergroup comparison test (prospective observational study)
* Implement while hiding the patient's condition from the confocal laser scanning microscopy photographer and the person in charge of image analysis.

Management information
Registered date
2018 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033797

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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