A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
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
- Double (Participant, Investigator)
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
- •Bilateral cataract surgery
- •Avoid disallowed medications throughout study
排除标准
- •Contraindications to the use of the test agents
- •Known allergy or sensitivity to the test agents or components
- •History of steroid response following topical administration of corticosteroids in the eye
- •Wore contact lenses 48 hours prior to Visit 1
- •An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
- •Any significant illness that could be expected to interfere with study
- •Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery
研究组 & 干预措施
Prednisolone and Tobramycin
Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.
干预措施: Prednisolone and Tobramycin (Drug)
Prednisolone
Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
时间窗: 2 days
Comparison of aqueous humor concentrations of prednisolone acetate at various time points
次要结局
未报告次要终点