Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059716) titled 'A Phase III Clinical Study of CHO in Subjects with Ocular Discomfort' on Nov. 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - ROHTO pharmaceutical CO.,LTD

Condition: Condition - Subjects who have subjective symptoms of ocular dryness and also experience eye fatigue or blurred vision. In addition, among soft contact lens wearers, those who feel discomfort while wearing contact lenses are included. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of CHO administered as 1 to 2 drops per dose, four times daily for two weeks, in subjects with subjective symptoms of ocular dryness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Over 2weeks

Eligibility: Age-lower limit - 12 years-old = 1) 2)Subjects who have subjective symptoms of eye fatigue or blurred vision (score >= 1) 3)Subjects who feel discomfort while wearing contact lenses [applicable only to soft contact lens wearers] (score >= 1) 4)Subjects who habitually wear soft contact lenses (5 days or more per week) [applicable only to soft contact lens wearers] (2) Subjects whose mean scores for both eyes during the 3 days prior to the start of study drug administration are >= 1.0 for all of the following symptoms: -Eye dryness -Eye fatigue or blurred vision -Discomfort while wearing contact lenses [applicable only to soft contact lens wearers] Key exclusion criteria - (1) Subjects whose tear film break-up time (BUT) in either eye or both eyes is <= 5 seconds at the screening visit. (2) Subjects who have used over-the-counter (OTC) artificial tears within 3 days prior to the start of study drug administration. (3) Subjects who have used any ophthalmic preparations (excluding OTC artificial tears) or ophthalmic ointments within 7 days prior to the start of study drug administration. (4) Subjects who have used corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications for ophthalmic diseases (both are administered systemically and topically to the head or face, including nasal and ear drops) within 7 days prior to the start of study drug administration. Target Size - 70

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2021 Year 08 Month 06 Day Date of IRB - 2021 Year 09 Month 10 Day Anticipated trial start date - 2021 Year 10 Month 13 Day Last follow-up date - 2021 Year 12 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068298

Disclaimer: Curated by HT Syndication.