The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment with a Dexamethasone Intracanalicular Insert - the CYTODEX Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pharmacokinetics in Aqueous Humor Samples
研究概览
简要总结
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
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
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male of female, aged 55 or older
- •Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract
- •Willing to comply with study instructions, agree to make study appointments, and complete the course of the study
- •Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate
排除标准
- •Known allergy or contraindication to the test article or its components
- •Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health
- •History of any illness that could be expected to interfere with the study
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study
- •May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria
- •Subject has active corneal, conjunctival, or canalicular infections, including:
- •Epithelial herpes simplex keratitis (dendritic keratitis)
- •Varicella
- •Mycobacterial infections
- •Fungal diseases of the eye
- •Dacryocystitis
研究组 & 干预措施
Dextenza (Group A)
Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery
干预措施: Dexamethasone Ophthalmic implant (Drug)
Dextenza (Group B)
Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery
干预措施: Dexamethasone Ophthalmic implant (Drug)
Dextenza (Group C)
Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery
干预措施: Dexamethasone Ophthalmic implant (Drug)
Dextenza (Group D)
Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery
干预措施: Dexamethasone Ophthalmic implant (Drug)
Dextenza (Group E)
Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery
干预措施: Dexamethasone Ophthalmic implant (Drug)
结局指标
主要结局
Pharmacokinetics in Aqueous Humor Samples
时间窗: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Concentration of inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax).
次要结局
- Correlation between dexamethasone levels and inflammatory cytokines(1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion)
研究者
Frank A. Bucci, Jr., M.D.
Medical Director
Bucci Laser Vision Institute