JRCT ID: jRCT1031220298
Registered date:27/08/2022
Mucosta trial
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Patients with dry eye complicated by Sjogren's syndrome |
Date of first enrollment | 27/08/2022 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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. |
Outcome(s)
Primary Outcome | Change in fluorescein staining score (van Bijsterfeld method) from the start of treatment (Day 1) to Week 12 |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 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. |
Exclude criteria | 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. |
Related Information
Primary Sponsor | Shimizu Daisuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | Clinical Research Initiation-Fund (of Chiba University Hospital) |
Secondary ID(s) |
Contact
Public contact | |
Name | Daisuke Shimizu |
Address | 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677 |
Telephone | +81-43-222-7171 |
ayga0466@chiba-u.jp | |
Affiliation | Chiba University Hospital |
Scientific contact | |
Name | Daisuke Shimizu |
Address | 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677 |
Telephone | +81-43-222-7171 |
ayga0466@chiba-u.jp | |
Affiliation | Chiba University Hospital |