Dose-response study of OPC-12759 ophthalmic suspension

Otsuka Pharmaceutical Co., Ltd.0 个研究点开始时间: 2005年9月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Inclusion criteria
•1. Males or females;
•2. Out patient;
•3. 20 years of age or older;
•4. Subjective complaint of dry eye that has been present for minimum 20 months;
•5. Primary ocular discomfort severity is moderate to severe;
•6. Corneal - conjunctival damage is moderate to severe;
•7. Unanesthetized Schirmer's test score of 7mm/5minutes or less;
•8. Best corrected visual acuity of 0.2 or better in both eyes.
•Exclusion criteria
•1. Presence of anterior segment disease or disorder other than that associated with keratoconjuntivitis sicca;
•2. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
•3. Anticipated use of contact lens during the study;
•4. Any history of ocular surgery within 12 months ;
•5. Female patients who are pregnant, possibly pregnant or breast feeding;
•6. Known hypersensitivity to any component of the study drug or procedual medications;
•7. Receipt of any investigational product within 4 months.

发起方