Tokyo, May 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061590) titled 'Prospective Study of TRPV1 Antagonist for Photoallodynia in Dry Eye' on May 15.

Study Type: Observational

Primary Sponsor: Institute - Tokyu Hospital

Condition: Condition - Dry Eye, Photophobia Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 80

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070468

Disclaimer: Curated by HT Syndication.