Mucosta trial (Mucosta trial)
- Conditions
- Patients with dry eye complicated by Sjogren's syndrome
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Change in fluorescein staining score Day 1 to Week 12 Change in fluorescein staining score (van Bijsterfeld method) from the start of treatment (Day 1) to Week 12
- Secondary Outcome Measures
Name Time Method Dry Eye related Quality of life Score Day 1 to Weeks 4 and 12 The following changes from the start of treatment (Day 1) to Weeks 4 and 12
Tear film break-up time Day 1 to Weeks 4 and 12 The following changes from the start of treatment (Day 1) to Weeks 4 and 12
Tear meniscus Day 1 to Weeks 4 and 12 The following changes from the start of treatment (Day 1) to Weeks 4 and 12
Schirmer test Day 1 to Weeks 4 and 12 The following changes from the start of treatment (Day 1) to Weeks 4 and 12
Change in fluorescein staining score (FCS) Day 1 to Weeks 4 and 12 The following changes from the start of treatment (Day 1) to Weeks 4 and 12