ate phase 2 study of OPC-12759 ophthalmic suspension

Otsuka Pharmaceutical Co., Ltd.0 个研究点开始时间: 2007年5月21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. Ocular discomfort severity is moderate to severe; 6. Corneal - conjunctival damage is moderate to severe; 7. Unanesthetized Schirmer's test score of 5mm/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. Ocular hypertention pattient or glaucoma patient with ophthalmic solutin; 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 Patient 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