Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Otsuka Pharmaceuticals Co., Ltd.0 个研究点目标入组 180 人开始时间: 2009年4月22日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. Out patient;
•2. Subjective complaint of dry eye that has been present for minimum 20 months;
•3. Ocular discomfort severity is moderate to severe;
•4. Corneal-conjunctival damage is moderate to severe;
•5. Unanesthetized Schirmer's test score of 5mm/5minutes or less;
•6. Best corrected visual acuity of 0.2 or better in both eyes.

•1. Presence of anterior segment disease or disorder other than that associated with keratocojunctivitis sicca;
•2. Ocular hypertension or glaucoma patients with ophthalmic solution;
•3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
•4. Anticipated use of contact lens during the study;
•5. Patients with punctal plug;
•6. Any history of ocular surgery within 12 months;
•7. Female patients who are pregnant, possibly pregnant or breast feeding;
•8. Known hypersensitivity to any component of the study drug or procedual medications;
•9. Receipt of any investigational product within 4 months.

发起方

Otsuka Pharmaceuticals Co., Ltd.