UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063279 |
|---|---|
| Receipt number | R000072422 |
| Scientific Title | Effect of Eyewash in Patients with Dry Eye: A Randomized, Open-Label, Parallel-Group Comparative Study |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 10:55:10 |
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Basic information
Public title
Effect of Eyewash in Patients with Dry Eye: A Randomized, Open-Label, Parallel-Group Comparative Study
Acronym
Effect of Eyewash in Patients with Dry Eye
Scientific Title
Effect of Eyewash in Patients with Dry Eye: A Randomized, Open-Label, Parallel-Group Comparative Study
Scientific Title:Acronym
Effect of Eyewash in Patients with Dry Eye
Region
| Japan |
Condition
Condition
Dry Eyes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of eyewash on dry eye symptoms in patients with dry eye against a no-eyewash control.
Basic objectives2
Others
Basic objectives -Others
To confirm the effects of eyewash on dry eye.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Tear Film Break-Up Time (BUT) from baseline (week 0) to week 4 of the intervention
Key secondary outcomes
1)Superficial Punctate Keratitis (SPK) score / MOT test
2)Tear volume
3)Quantification of tear components
4)Pain assessment
5)Subjective symptom scores (J-OSDI, DEQS)
6)Incidence of adverse events
7)Change in Tear Film Break-Up Time (BUT) from baseline (week 0) to week 2 of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Eyewash with 5 mL of physiological saline 3 times daily for 4 weeks.
Interventions/Control_2
Continue normal daily life without eyewash.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 20 to 74 years at the time of informed consent.
2)Patients with subjective symptoms such as ocular discomfort or visual function abnormalities (J-OSDI score >=13 or DEQS score >=15).
3)Fluorescein BUT <=5 seconds.
4)Patients who have received sufficient explanation regarding the purpose and contents of the study, fully understood it, voluntarily agreed to participate, and provided written informed consent.
Key exclusion criteria
1)Currently receiving medication or outpatient treatment for any serious disease.
2)History or current presentation of psychiatric, diabetes, liver, kidney, gastrointestinal, cardiac, respiratory, peripheral vascular, or other serious diseases.
3)History of drug allergy.
4)Hypersensitivity to investigational or testing agents.
5)Pregnant, lactating, or planning pregnancy.
6)SPK score >=6 by fluorescein staining.
7)Answering "All of the time"/"Most of the time" to J-OSDI eye pain, or "Constantly"/"Mostly" to DEQS eye pain.
8)Ocular surface surgery (inc. LASIK/IOL) within 6 months, or intraocular surgery within 3 months prior to screening.
9)Corneal/conjunctival abnormalities or non-dry eye ocular surface diseases.
10)Current contact lens users unable to discontinue after consent.
11)Unable to discontinue routine (>=3x/week) intake of omega-3 drugs/supplements/functional foods after consent. Unable to discontinue eyewashes, eye shampoos, or warming/cooling eye devices after consent.
12)Routine use of eye drops containing sodium hyaluronate, diquafosol sodium, rebamipide, or motsugibatorepu. Unable to discontinue/expected to use OTC/prescription anticholinergics (e.g., belladonna alkaloids, isopropamide iodide, butylscopolamine bromide, scopolia extract, pirenzepine hydrochloride hydrate, scopolamine hydrobromide hydrate).
13)Daily alcohol consumption >60g.
14)Excessive smoking (>=21 cigarettes/day).
15)Planning major lifestyle changes (e.g., long-term travel, diet, sleep, exercise).
16)Extremely irregular dietary habits.
17)Currently in another trial, within 4 weeks of completing a previous trial, or planning to join another trial.
18)Deemed inappropriate by investigators.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Tagawa |
Organization
Hokkaido University Hospital
Division name
ophthalmology
Zip code
060-8648
Address
14-5 Kita-ku, Sapporo, Hokkaido
TEL
011-706-5944
yocchinn0127@gmail.com
Public contact
Name of contact person
| 1st name | Shuu |
| Middle name | |
| Last name | Imai |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
562-0029
Address
4-1-66 Saito Aokita, Minoh, Osaka
TEL
090-6034-4099
Homepage URL
sh.imai@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo City, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 15 | 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 | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072422
