Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Resolution of anterior chamber inflammation
研究概览
简要总结
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
详细描述
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
排除标准
- •Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
研究组 & 干预措施
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg
Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
干预措施: Omidria (Drug)
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg
Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
干预措施: Dextenza (dexamethasone ophthalmic insert) 0.4mg (Drug)
Omidria + Dexycu
Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
干预措施: Omidria (Drug)
Omidria + Dexycu
Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
干预措施: Dexycu, 9% Intraocular Suspension (Drug)
Omidria + Prednisolone Acetate 1%
Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
干预措施: Omidria (Drug)
Omidria + Prednisolone Acetate 1%
Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
干预措施: Prednisolone Acetate 1% (Drug)
结局指标
主要结局
Resolution of anterior chamber inflammation
时间窗: Assessed at day 30 post-operatively
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
次要结局
- Resolution of postoperative pain(Assessed at day 8 post-operatively)