UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063108 |
|---|---|
| Receipt number | R000072235 |
| Scientific Title | Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 01:02:48 |
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Basic information
Public title
Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye
Acronym
Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye
Scientific Title
Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye
Scientific Title:Acronym
Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this cross-sectional study is to evaluate corneal sensory nerve morphology, corneal sensation and pain, tear film break-up time (TFBUT), and other subjective and objective findings related to dry eye disease in three populations: healthy adults, asymptomatic individuals with shortened TFBUT (TFBUT-shortened subjects), and patients diagnosed with dry eye disease.
Through comparative assessment across these groups, the study aims to exploratorily identify characteristic morphological changes in corneal sensory nerves associated with the progression of dry eye disease and to clarify the influence of these morphological changes on corneal sensory function and pain perception.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in corneal sensory nerve morphological parameters among classified groups
Key secondary outcomes
Differences in subjective symptom scores, tear osmolarity, wavefront aberrations, TFBUT, keratoconjunctival epithelial damage scores, corneal sensation/pain, and tear volume among classified groups
Correlations between corneal sensory nerve morphological parameters and each index
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects aged 18 years or older at the time of providing informed consent
Subjects who are capable of providing written informed consent of their own free will
Key exclusion criteria
Subjects with comorbid or past ocular diseases other than dry eye that affect the ocular surface, corneal sensation/pain, or nerve morphology evaluation
Subjects with a history of corneal surgery, cataract surgery, LASIK, corneal transplantation, or other ocular surgeries
Subjects with comorbid or past diabetes mellitus or other systemic diseases affecting the nervous system
Subjects who are otherwise judged inappropriate for participation by the principal investigator or sub-investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Taiichiro |
| Middle name | |
| Last name | Chikama |
Organization
Hiroshima University
Division name
Department of Ophthalmology and Visual Science, Hiroshima University Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5247
yurie0429@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | yurie |
| Middle name | |
| Last name | shimizu |
Organization
Hiroshima University
Division name
Department of Ophthalmology and Visual Science
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5247
Homepage URL
yurie0429@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
Epidemiological Research Ethics Committee of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
Tel
082-257-1520
yurie0429@hiroshima-u.ac.jp
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
| 2026 | Year | 09 | Month | 30 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, cross-sectional observational study evaluating corneal nerve morphology, corneal sensation, and ocular pain in dry eye patients, asymptomatic subjects with shortened TFBUT, and healthy controls.
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072235
