Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063279) titled 'Effect of Eyewash in Patients with Dry Eye: A Randomized, Open-Label, Parallel-Group Comparative Study' on Oct. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kobayashi Pharmaceutical Co., Ltd.

Condition: Condition - Dry Eyes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effects of eyewash on dry eye symptoms in patients with dry eye against a no-eyewash control. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Eyewash with 5 mL of physiological saline 3 times daily for 4 weeks. Interventions/Control_2 - Continue normal daily life without eyewash.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1)Japanese males and females aged 20 to 74 years at the time of informed consent. 2)Patients with subjective symptoms such as ocular discomfort or visual function abnormalities (J-OSDI score >=13 or DEQS score >=15). 3)Fluorescein BUT =6 by fluorescein staining. 7)Answering "All of the time"/"Most of the time" to J-OSDI eye pain, or "Constantly"/"Mostly" to DEQS eye pain. 8)Ocular surface surgery (inc. LASIK/IOL) within 6 months, or intraocular surgery within 3 months prior to screening. 9)Corneal/conjunctival abnormalities or non-dry eye ocular surface diseases. 10)Current contact lens users unable to discontinue after consent. 11)Unable to discontinue routine (>=3x/week) intake of omega-3 drugs/supplements/functional foods after consent. Unable to discontinue eyewashes, eye shampoos, or warming/cooling eye devices after consent. 12)Routine use of eye drops containing sodium hyaluronate, diquafosol sodium, rebamipide, or motsugibatorepu. Unable to discontinue/expected to use OTC/prescription anticholinergics (e.g., belladonna alkaloids, isopropamide iodide, butylscopolamine bromide, scopolia extract, pirenzepine hydrochloride hydrate, scopolamine hydrobromide hydrate). 13)Daily alcohol consumption >60g. 14)Excessive smoking (>=21 cigarettes/day). 15)Planning major lifestyle changes (e.g., long-term travel, diet, sleep, exercise). 16)Extremely irregular dietary habits. 17)Currently in another trial, within 4 weeks of completing a previous trial, or planning to join another trial. 18)Deemed inappropriate by investigators. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 09 Day Anticipated trial start date - 2026 Year 10 Month 19 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072422

Disclaimer: Curated by HT Syndication.