UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061171 |
|---|---|
| Receipt number | R000070002 |
| Scientific Title | Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/06 16:40:09 |
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Basic information
Public title
Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye
Acronym
Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye
Scientific Title
Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye
Scientific Title:Acronym
Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye
Region
| Japan |
Condition
Condition
Myopia / Dry Eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the effects of Motugibatrep ophthalmic suspension on visual function and the physical properties of soft contact lens (SCL) in patients with dry eye who wear SCLs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in visual acuity from baseline to week 4 after initiation of wearing SCLs
Key secondary outcomes
1.Mean change in contrast sensitivity from baseline to week 4
2.Mean change in the DEQS symptom score (6 items) from baseline to week 4
3.Mean change in the J-CLDEQ-8 from baseline to week 4
4.Mean change in BUT from baseline to week 4
5.Mean change in corneal staining score using National Eye Institute (NEI)/Industry Workshop grading scale from baseline to week 4
6.Mean change in conjunctival staining score using van Bijsterveld score from baseline to week 4
7.Physical properties of SCLs at week 2 (compared to unused lenses)
1)Shape and appearance
2)Diameter
3)Base curve
4)Vertex power
5)Thickness
6)Optical transmittance
7)Water content
8.Frequency and severity of each adverse event
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 to 40 at consenting
2.Patients capable of providing written informed consent by their own free will
3.Patients who meet the diagnostic criteria for dry eye (BUT: 5 seconds or less, with subjective symptoms) and have been prescribed ophthalmic Motugibatrep suspension during routine medical care
4.Patients who routinely wear bi-weekly replacement SCLs (spherical) in both eyes (6 hours or more per day, 5 days or more per week)
5.Patients with visual acuity of 0.8 or higher while wearing SCLs
6.Patients capable of properly performing SCL care, such as cleaning
7.Patients whom the physician judges can be appropriately evaluated for the efficacy and safety of this study
Key exclusion criteria
1.Patients wearing multifocal or astigmatism-correcting SCLs
2.Patients wearing colored SCLs
3.Patients who have used other dry eye medications* within 14 days before consenting
*Patients who have used artificial tears can be registered.
4.Patients with corneal erosions requiring treatment, or patients with punctal plugs inserted
5.Individuals requiring a legal representative
6.Individuals with other conditions that the responsible investigator or subinvestigator deemed unsuitable for participation in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koh |
| Middle name | |
| Last name | Shizuka |
Organization
Yukoukai General Hospital
Division name
Ophthalmology
Zip code
567-0058
Address
25-1 Nishi-Yokogawa-cho, Izumi City, Osaka-fu
TEL
072-641-2488
cizciz@gmail.com
Public contact
Name of contact person
| 1st name | Koh |
| Middle name | |
| Last name | Shizuka |
Organization
Yukoukai General Hospital
Division name
Ophthalmology
Zip code
545-0021
Address
25-1 Nishi-Yokogawa-cho, Izumi City, Osaka-fu
TEL
072-641-2488
Homepage URL
cizciz@gmail.com
Sponsor or person
Institute
Yukoukai General Hospital
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
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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 | 04 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070002
