A double-blinded, randomised, clinical trial about the effect of rebamipide ophthalmic suspension in dry eye with the Sjogren syndrome patients. (Mucosta trial)

未提供0 个研究点目标入组 20 人开始时间: 待定最近更新: 2025年4月10日

试验速览

暂无简介。

•Patients who meet all of the following criteria will be considered
•(1) Written consent has been obtained from the patient or a surrogate
•(2) Men and women who are at least 18 years of age at the time of consent acquisition.
•(3) Patient must have a diagnosis of Sjogren's syndrome based on the revised diagnostic criteria of the Ministry of Health in
•(4) Patient has a diagnosis of dry eye based on the revised dry eye practice guideline criteria by the 2019 Dry Eye Study Group Practice Guideline Development Committee.

•Patients who meet all of the following criteria will be considered.
•(1) Patients with active inflammatory ocular or eyelid disease.
•(2) Patients with eyelid closure defects.
•(3) Patients with a history of graft-versus-host disease.
•(4) Other persons deemed by the principal investigator or subinvestigator to be inappropriate for the safe conduct of this study.

Change in fluorescein staining score

时间窗: Day 1 to Week 12

Change in fluorescein staining score (van Bijsterfeld method) from the start of treatment (Day 1) to Week 12

Dry Eye related Quality of life Score(Day 1 to Weeks 4 and 12)
Tear film break-up time(Day 1 to Weeks 4 and 12)
Tear meniscus(Day 1 to Weeks 4 and 12)
Schirmer test(Day 1 to Weeks 4 and 12)
Change in fluorescein staining score (FCS)(Day 1 to Weeks 4 and 12)

发起方

未提供