UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058602 |
|---|---|
| Receipt number | R000067006 |
| Scientific Title | Investigating the Relationship Between Air Pollution and Ocular Diseases |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/25 20:23:22 |
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Basic information
Public title
Investigating the Relationship Between Air Pollution and Ocular Diseases
Acronym
Investigating the Relationship Between Air Pollution and Ocular Diseases
Scientific Title
Investigating the Relationship Between Air Pollution and Ocular Diseases
Scientific Title:Acronym
Investigating the Relationship Between Air Pollution and Ocular Diseases
Region
| Japan | Asia(except Japan) |
Condition
Condition
ocular disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the relationship between exposure to air pollutants particularly volatile organic compounds and fine particulate matter and the development or progression of ocular diseases such as age related macular degeneration dry eye disease conjunctivitis and diabetic retinopathy This research aims to evaluate both epidemiological associations and underlying biological mechanisms with a focus on oxidative stress and inflammatory responses induced by air pollution Additionally ocular surface infections will be investigated through ocular surface washes and the culture of particles collected from the eyelid margins
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Change in subjective symptom score (JACQLQ)
2.Changes in objective symptom score (JACQLQ)
3.Changes in conjunctival injection score
4.Identification of bacteria on the eye
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eyewash
Interventions/Control_2
Bike commuting or car commuting
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
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with ocular disease or ocular symptoms
Key exclusion criteria
1 Subjects with a past history of ocular surgery.
2. Subjects who can not use eyewash solution.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Tsurumi University School of Dentistry
Division name
Department of Ophthalmology
Zip code
230-0063
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama City, Kanagawa, Japan
TEL
045-580-8500
mimurat-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Tsurumi University School of Dentistry
Division name
Department of Ophthalmology
Zip code
230-0063
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama City, Kanagawa, Japan
TEL
045-580-8500
Homepage URL
mimurat-tky@umin.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Tatsuya Mimura
Funding Source
Organization
Tsurumi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tsurumi University Dentistry
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama City, Kanagawa, Japan
Tel
045-580-8500
mimurat-tky@umin.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
神奈川県
Institutions
Institutions
鶴見大学（神奈川県）、Rohto Laboratories Indonesia (West Jakarta City, Jakarta)、ロート製薬株式会社（京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067006
