Skip to content

Prospective Study of TRPV1 Antagonist for Photoallodynia in Dry Eye

Efficacy of Topical TRPV1 Antagonist (Motugivatrep) on Neuropathic Photoallodynia in Dry Eye Disease: A Prospective Longitudinal Study Using Mixed-Effects Modeling - Motugivatrep for Photoallodynia in DED

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061590
Enrollment
80
Registered
2026-05-15
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Photophobia

Interventions

None listed

Sponsors

Tokyu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHoriguchi Hiroshi

Tokyu Hospital Ophthalmology

hhiro@jikei.ac.jp+81-3-3718-3331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026