JPRN-jRCT1031220298
Recruiting
Phase 4
A double-blinded, randomised, clinical trial about the effect of rebamipide ophthalmic suspension in dry eye with the Sjogren syndrome patients. - Mucosta trial
Shimizu Daisuke0 sites40 target enrollmentAugust 27, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with dry eye complicated by Sjogren's syndrome
- Sponsor
- Shimizu Daisuke
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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