Dry eye
Conditions
Interventions
SPDEF mRNA expression levels on ocular surface: more than 6.0.
SPDEF mRNA expression levels on ocular surface: less than 6.0 more than 1.7.
SPDEF mRNA expression levels on ocular surface: Less than 1.
Sponsors
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sjogren syndrome dry eye patient 1) Male or female of age of 20 years or older 2) Patients who provided written informed consent for participating in this study. 3) Patients who are diagnosed as Sjogren syndrome dry eye according to both Sjogren syndrome diagnostic criteria and the Japan dry eye diagnostic criteria in 2006. 4) The patient who has either sensation of xerosis or foreign body sensation as main complication, and has 50 points or more of VAS score of the main symptom.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serial investigation of the therapeutic effect of rebamipide ophthalmic solution using the ocular surface biomarker in dry eye disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Search of the ocular surface biomarker in the treatment of dry eye disease. | — |
Countries
Japan
Contacts
Public ContactJun Shoji
Nihon University School of Medicine Division of Ophthalmology, Department of Visual Sciences
Outcome results
None listed