UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061457 |
|---|---|
| Receipt number | R000070325 |
| Scientific Title | A prospective evaluation of the accuracy of an eye-drop bottle sensor for detecting eye-drop instillation behavior using 0.2% fluorescein ophthalmic solution and contact lens staining |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/06 08:35:11 |
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Basic information
Public title
Accuracy evaluation of an eye-drop bottle sensor for detecting eye-drop instillation behavior
Acronym
Eye-drop bottle sensor accuracy study
Scientific Title
A prospective evaluation of the accuracy of an eye-drop bottle sensor for detecting eye-drop instillation behavior using 0.2% fluorescein ophthalmic solution and contact lens staining
Scientific Title:Acronym
Fluorescein-based evaluation of an eye-drop bottle sensor
Region
| Japan |
Condition
Condition
Various ophthalmological diseases including glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the accuracy of an eye-drop bottle sensor in detecting eye-drop instillation behavior by determining whether eye drops actually enter the eye when the sensor classifies the action as eye-drop instillation behavior.
Basic objectives2
Others
Basic objectives -Others
Observational study or interventional study: to be confirmed. Because 0.2% fluorescein ophthalmic solution is administered for research purposes, registration as an interventional study may be more appropriate.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of participants in whom the eye drop is judged to have actually entered the eye, based on contact lens staining after administration of 0.2% fluorescein ophthalmic solution, among those classified by the eye-drop bottle sensor and deep learning algorithm as having performed eye-drop instillation behavior.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants will wear a non-powered protective contact lens before eye-drop instillation. A magnified image of the eye will be obtained using a slit-lamp microscope before instillation. Participants will then instill 0.2% fluorescein ophthalmic solution using an eye-drop bottle equipped with an eye-drop bottle sensor. After instillation, another magnified image of the eye will be obtained using a slit-lamp microscope. If the contact lens is stained, the eye drop will be judged to have entered the eye. If the contact lens is not stained, the eye drop will be judged not to have entered the eye. After assessment, the contact lens will be removed. Data recorded by the eye-drop bottle sensor will be classified by deep learning as either eye-drop instillation behavior present or eye-drop instillation behavior absent.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. An outpatient at Tsukazaki Hospital 2. Patients who have received an explanation of the study and provided written informed consent. 3. Patients who are able to perform eye-drop instillation while wearing a protective contact lens according to the study procedures.
Key exclusion criteria
1. Patients with a history of hypersensitivity or allergy to fluorescein sodium. 2. Patients for whom contact lens wear is difficult or inappropriate. 3. Patients with active conjunctivitis, severe corneal epithelial disorder, ocular infection, or other ocular conditions that may interfere with the study procedures. 4. Patients judged by the principal investigator or sub-investigator to be unsuitable for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Nishimura |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
671-1277
Address
68-1 Aboshi Waku, Himeji, Hyougo
TEL
0792-72-8555
K.Nishimura@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Nishimura |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
671-1277
Address
68-1 Aboshi Waku, Himeji, Hyougo
TEL
0792-72-8555
Homepage URL
k.nishimura@tsukazaki-eye.net
Sponsor or person
Institute
Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Topcon
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukazaki Hospital Ethics Committee
Address
68-1 Aboshi Waku, Himeji, Hyougo
Tel
0792-72-8555
k.nishimura@tsukazaki-eye.net
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 | 05 | Month | 07 | 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
100
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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 05 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070325
