UMIN-CTR Clinical Trial

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

Dry eye patients and healthy adults

Classification by specialty

Ophthalmology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

COSMOS study Group

Institute

Department

Personal name

Organization

Senju Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団慶幸会　ピーワンクリニック

Date of disclosure of the study information

2018

Year

04

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2018

Year

04

Month

09

Day

Last modified on

2019

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033797