Dry eye patients and healthy adults
Conditions
Interventions
None listed
Sponsors
COSMOS study Group
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHiroo Homma
IDD, Inc. Regulatory Affairs
Outcome results
None listed