A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 381
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
研究概览
简要总结
This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
- •Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control [condom or diaphragm and spermicide] for the duration of the study).
- •Male subjects should use medically reliable contraception methods such as condom or vasectomy.
- •Subjects are able to perform the activities required by the study protocol and have provided written informed consent.
排除标准
- •Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
- •Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
- •Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
- •Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
- •Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to Visit 1.
研究组 & 干预措施
RLD - Generic Loteprednol Etabonate
Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate
干预措施: Reference Listed Drug (RLD) (Drug)
Generic Loteprednol Etabonate - RLD
Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)
干预措施: Generic Loteprednol Etabonate (Drug)
Generic Loteprednol Etabonate - RLD
Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD)
干预措施: Reference Listed Drug (RLD) (Drug)
RLD - Generic Loteprednol Etabonate
Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate
干预措施: Generic Loteprednol Etabonate (Drug)
结局指标
主要结局
Pharmacokinetic (PK) assessed by Area Under the Curve (AUC)
时间窗: upon study completion, up to 1 year
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
Pharmacokinetic (PK) assessed by rate of drug absorption (Cmax)
时间窗: upon study completion, up to 1 year
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
次要结局
未报告次要终点