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Search for the ocular surface biomarker in the Sjogren's syndrome dry eye patients treated with rebamipide ophthalmic solution.

Phase 4
Conditions
Dry eye
Registration Number
JPRN-UMIN000017620
Lead Sponsor
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Sjogren syndrome dry eye patient 1) Patients with anterior segment disease, including blepharitis, lagophthalmos, blepharospasm, iritis and conjunctivochalasis other than dry eye (History is excluded). 2) Patients who cannot discontinue eye drops (include all eye drops such as prescribed drug and OTC medicine) except for the study drug or the control drug from the study initiation until the end of study treatment or who expect to use those drugs 3) Patients with punctal plug or patients whose punctal plug fell off within three months prior to the study drug initiation examination. 4) Patients with a history of surgical punctual occlusion are also excluded. 5) Patients with a history of surgery of the ocular surface within 12 months. 6) Patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 7) Contact lens wearer. 8) Patients with the change of the systemic medicament during study period. 9) Patients who have difficulty in sampling. 10) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serial investigation of the therapeutic effect of rebamipide ophthalmic solution using the ocular surface biomarker in dry eye disease.
Secondary Outcome Measures
NameTimeMethod
Search of the ocular surface biomarker in the treatment of dry eye disease.
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