Dry eye
Conditions
Interventions
Dry eye (+) Rebamipide eye drop (+) Sodium hyaluronate eye drop (-)
Dry eye (+) Rebamipide eye drop (-) Sodium hyaluronate eye drop (+)
Dry eye (-) Rebamipide eye drop (-) Sodium hyaluronate
Sponsors
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patients with dry eye. 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 dry eye according to the Japan dry eye diagnostic criteria in 2006. 4) Patients with VAS score of 50 or greater in at least one item in symptom. b) Non-dry eye patients. 1) Male or female of age of 20 years or older. 2) Patients, who are visiting the hospital for existing ocular disease other than anterior segment disease, do not have abnormal findings in anterior segment, and are not receiving treatment with eye drops or contact lens. 3) Patients with VAS score of less than 50 in all items for symptom. 4) Patients who understood the purpose of this study and from whom written consent was obtained.
Exclusion criteria
Exclusion criteria: a) Patients with dry eye. 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. Patients with a history ofsurgical punctual occlusion are also excluded. 4) Patients with a history of surgery of the ocular surface within 12 months, or patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 5) Patients who have difficulty in sampling. 6) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate. b) Non-dry eye patients 1) Patients with anterior segment disease. 2) Patients who used eye drops or the contact lens within two weeks prior to study initiation. 3) Patients with a history of surgery of the ocular surface within 12 months or patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 4) Patients who have difficulty in sampling. 5) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of therapeutic effect of dry eye between rebamipide eye drop and hyaluronate sodium eye drop using biomarker in tears. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of biomarker in tears that is useful for dry eye practice by comparing patients with dry eye and non-dry eye patients. | — |
Countries
Japan
Contacts
Public ContactJun Shoji
Nihon University School of Medicine Division of Ophthalmology, Department of Visual Sciences
Outcome results
None listed