UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057941 |
|---|---|
| Receipt number | R000066238 |
| Scientific Title | Web-based survey for dry eye patients (including potential patients) |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2026/01/13 16:29:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Web-based survey for dry eye patients (including potential patients)
Acronym
Web-based survey for dry eye patients (including potential patients)
Scientific Title
Web-based survey for dry eye patients (including potential patients)
Scientific Title:Acronym
Web-based survey for dry eye patients (including potential patients)
Region
| Japan |
Condition
Condition
Dry eye patients and potential dry eye patients
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use a web-based questionnaire to elucidate the needs of dry eye patients regarding eye drops for dry eye, and to clarify the awareness of potential dry eye patients about the condition and its treatment.
Basic objectives2
Others
Basic objectives -Others
To elucidate the needs for eye drops in dry eye disease and the perceptions of dry eye disease and its treatment across various subgroups, including age, gender, comorbidities, and other relevant factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Basic information (gender, age, presence of concurrent eye diseases, corrective devices, history of eye-related surgeries)
2. Hospital visits and prescription status (period from symptom awareness to first visit, reason for consultation (or planning to consult), reasons for not seeking or discontinuing treatment, types of prescribed eye drops, usage status)
3. Eye symptoms (measures taken for symptoms, eye symptoms (before treatment, before countermeasures, current), most troublesome symptoms (before treatment, before countermeasures, current))
4. Desired treatment and tolerance (satisfaction and dissatisfaction with eye drops, desired effects from eye drops, expected time for effects to appear, acceptable number of eye drop applications)
5. Disease awareness (recognition of the need for continued treatment, reasons for this belief, awareness of risks if left untreated)
Key secondary outcomes
Responses to questionnaires targeting potential dry eye patients will be considered as secondary outcomes.
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 must meet the following criteria:
Dry Eye Patients
a) Diagnosed with dry eye by a physician
b) Last medical visit within the past 6 months
c) Experience of using prescribed eye drops for at least 1 month
d) Continuing to use prescribed eye drops
Potential Dry Eye Patients
2_1. Those who have discontinued prescribed eye drops
a) Diagnosed with dry eye by a physician
b) Experience of using prescribed eye drops for at least 1 month
c) Currently not using the prescribed eye drops
2_2. Undiagnosed individuals with self-perceived dry eye symptoms
a) Have self-perceived dry eye symptoms
b) Have not visited an ophthalmologist for dry eye diagnosis
Key exclusion criteria
Having no history of either or both of the following diseases:
a) Allergic conjunctivitis
b) Allergic rhinitis
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tajika |
Organization
Senju Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department, Research and Development Division
Zip code
650-0047
Address
6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
TEL
06-6201-2512
ttajika@senju.co.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Shibuya |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-5294-6254
Homepage URL
Yukiko.shibuya@intage.com
Sponsor or person
Institute
Senju Pharmaceutical Co., Ltd.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo,180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2025 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Published
Result
URL related to results and publications
https://jjmps.jp/login/?u=e9e2d07d2b78e9a36f10784c37112661
Number of participants that the trial has enrolled
1642
Results
Among 1,435 patients using prescribed eye drops,66.6% were female,59.5% aged 60 or older, and 88.7% used them at least 6 months. About 60% of consultation reasons involved persistence or worsening of subjective symptoms; "eye dryness" was most bothersome. Satisfaction was 50.1%, while "the expected effect was not achieved" was the top dissatisfaction. While 67.6% were willing to add another drop, this decreased to 48.8% among those using three or more medications.
Results date posted
| 2026 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were diagnosed with dry eye by a physician and have been continuously using prescribed eye drops.
Participant flow
Participants were recruited via an online panel for approximately one week between May and June 2025.
Adverse events
None
Outcome measures
1. Basic Information: Sex and age; history of ocular diseases; use of corrective devices; and history of ocular surgery.
2. Consultation and Prescription Status: Duration from onset of symptoms to the first consultation; reasons for seeking consultation; reasons for not seeking medical care or discontinuing visits; types of prescribed eye drops; and usage status.
3. Ocular Symptoms: Ocular symptoms (before treatment/countermeasures and current); top three bothersome symptoms (before treatment/countermeasures and current); and measures taken to alleviate symptoms.
4. Desired Treatment and Tolerance: Satisfaction and dissatisfaction with prescribed eye drops; desired therapeutic effects; expected time to onset of effect; and acceptable number of eye drop medications.
5. Disease Awareness: Awareness of the need for continued treatment; reasons for this perception; and awareness of risks associated with leaving the condition untreated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as a questionnaire survey targeting patients with dry eye and those with potential dry eye.
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066238
