UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061590 |
|---|---|
| Receipt number | R000070468 |
| Scientific Title | Efficacy of Topical TRPV1 Antagonist (Motugivatrep) on Neuropathic Photoallodynia in Dry Eye Disease: A Prospective Longitudinal Study Using Mixed-Effects Modeling |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/15 17:37:09 |
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Basic information
Public title
Prospective Study of TRPV1 Antagonist for Photoallodynia in Dry Eye
Acronym
TRPV1 Antagonist for Dry Eye
Scientific Title
Efficacy of Topical TRPV1 Antagonist (Motugivatrep) on Neuropathic Photoallodynia in Dry Eye Disease: A Prospective Longitudinal Study Using Mixed-Effects Modeling
Scientific Title:Acronym
Motugivatrep for Photoallodynia in DED
Region
| Japan |
Condition
Condition
Dry Eye, Photophobia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that subjective symptoms associated with dry eye disease (DED), particularly photoallodynia and ocular pain, do not necessarily correlate with objective ocular surface damage. This study prospectively evaluates the efficacy of a topical TRPV1 antagonist (motugivatrep) for neuropathic photoallodynia associated with DED. Specifically, using linear mixed-effects (LME) modeling, we aim to statistically test the hypothesis that the symptomatic relief provided by motugivatrep represents a direct neuromodulatory effect that is independent of ocular surface healing or increased tear volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS (Numeric Rating Scale): Assessment of ocular pain and light-induced pain (scale of 0-10).
VLSQ-8 (Visual Light Sensitivity Questionnaire-8): Assessment of photophobia-related quality of life.
Safety and Tolerability: NRS assessment of instillation-site irritation (e.g., cooling or burning sensations).
Key secondary outcomes
Tear Meniscus Height (TMH): Non-invasive quantification using anterior segment OCT (CASIA2).
Corneal epithelial damage: NEI scale (range, 0-15 points).
Conjunctival damage: van Bijsterveld score (range, 0-9 points).
Tear Break-Up Time (TBUT): Assessment via fluorescein staining.
Covariates: Lens status (presence of cataract or intraocular lens), along with baseline TMH and vital staining scores.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients meeting the diagnostic criteria for dry eye disease.
2.Patients presenting with photoallodynia or ocular pain above a pre-specified threshold on the NRS or VLSQ-8.
3.Patients who understand the purpose of the study and provide written informed consent.
Key exclusion criteria
1.Glaucoma patients requiring two or more topical anti-glaucoma medications (Note: Patients well-controlled with a single agent are permitted).
2.Patients with active intraocular inflammation, such as active uveitis or severe allergic conjunctivitis.
3.Patients with moderate-to-severe cataract causing decreased visual acuity (Note: Mild cataract and pseudophakia [IOL] are permitted and will be treated as covariates in the analysis).
4.Other patients deemed inappropriate for study participation by the attending physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Horiguchii |
| Middle name | |
| Last name | Hiroshi |
Organization
Tokyu Hospital
Division name
Ophthalmology
Zip code
1450062
Address
3-27-2 Kita-Senzoku, Ota-Ku, Tokyo
TEL
+81-3-3718-3331
hhiro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Horiguchi |
| Middle name | |
| Last name | Hiroshi |
Organization
Tokyu Hospital
Division name
Ophthalmology
Zip code
1450062
Address
3-27-2 Kita-Senzoku, Ota-Ku, Tokyo
TEL
+81-3-3718-3331
Homepage URL
hhiro@jikei.ac.jp
Sponsor or person
Institute
Tokyu Hospital
Institute
Department
Personal name
Hiroshi Horiguchi
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyu Hospital
Address
3-27-2 Kita-Senzoku, Ota-Ku, Tokyo
Tel
+81-3-3718-3331
hhiro@jikei.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-arm, prospective observational study designed to investigate the mechanisms of dry eye-associated photoallodynia.
1. Observations: Subjective symptoms (NRS, VLSQ-8), clinical findings (NEI score, van Bijsterveld score, TBUT), and imaging metrics (TMH quantification via CASIA2, Lens status) will be collected at Baseline (Week 0), Week 2, and Week 4.
2. Statistical Analysis: A linear mixed-effects (LME) model will be employed to evaluate the neuromodulatory effects of a topical TRPV1 antagonist, independent of ocular surface improvements (NEI, TMH).
3. Confounding Control: Lens status (cataract severity), a critical confounder for photoallodynia, will be incorporated into the model as a covariate for statistical adjustment.
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070468
