Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 5
- 主要终点
- Change in Fluorescein Corneal Staining (FCS) Score From Baseline
研究概览
简要总结
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out patient
- •Subjective complaint of dry eye that has been present for minimum 20 months
- •Ocular discomfort severity is moderate to severe
- •Corneal - conjunctival damage is moderate to severe
- •Unanesthetized Schirmer's test score of 5mm/5minutes or less
- •Best corrected visual acuity of 0.2 or better in both eyes
排除标准
- •Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
- •Ocular hypertension patient or glaucoma patient with ophthalmic solution
- •Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
- •Anticipated use of contact lens during the study
- •Patient with punctal plug
- •Any history of ocular surgery within 12 months
- •Female patients who are pregnant,possibly pregnant or breast feeding
- •Known hypersensitivity to any component of the study drug or procedural medications
- •Receipt of any investigational product within 4 months.
研究组 & 干预措施
Rebamipide
Instillation,4 times/day for 4 weeks
干预措施: OPC-12759 Ophthalmic suspension (Drug)
Hyaluronate
Instillation,6 times/day for 4 weeks
干预措施: Hyalein Mini Ophthalmic solution (Drug)
结局指标
主要结局
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
时间窗: Baseline, Weeks4
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
时间窗: Baseline, Weeks4
LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
次要结局
未报告次要终点