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

Mucosta trial (Mucosta trial)

Tatsumi Tomoaki

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan

ttatsumi@chiba-u.jp

Shimizu Daisuke

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan

+81-43-222-7171

ayga0466@chiba-u.jp

Recruiting

Aug. 27, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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 1999.
(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.

Both

Patients with dry eye complicated by Sjogren's syndrome

Each study drug will be administered for a period of 12 weeks from the date of initiation of administration.

Mucosta group: Mucosta ophthalmic suspension is administered 4 times a day and observed at 0, 4 and 12 weeks.
Hyalein group: Hyalein ophthalmic suspension is administered 6 times a day and observed at 0, 4, and 12 weeks.

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

Secondary efficacy endpoints
The following changes from the start of treatment (Day 1) to Weeks 4 and 12
(1) Dry Eye related Quality of life Score
(2) Tear film break-up time
(3) Tear meniscus
(4) Schirmer test
(5) Change in fluorescein staining score (FCS)

Secondary safety endpoints
(1) Number and percentage of adverse events and serious adverse events
(2) Newly treated eye diseases and percentages

+81-43-226-2616

Aug. 15, 2022

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