Study on evaluation of therapeutic efficacy and search for a therapeutic biomarker in dry eye with rebamipide eye drop treatment.

Not Applicable

• Conditions: Dry eye

• Registration Number: JPRN-UMIN000009371
• Lead Sponsor: Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-01
• Study Completion: 2015-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of therapeutic effect of dry eye between rebamipide eye drop and hyaluronate sodium eye drop using biomarker in tears.

Secondary Outcome Measures

Name	Time	Method
Investigation of biomarker in tears that is useful for dry eye practice by comparing patients with dry eye and non-dry eye patients.