A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With AC Cell Count of Zero on Day 7
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.
详细描述
Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The population studied was comprised of males and females scheduled for unilateral cataract surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0). Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
- •Male or female 18 years or older
- •Receive, understand, and sign a copy of the written informed consent form
- •Be able to return for all study visits and willing to comply with all study-related instructions
排除标准
- •Subjects not meeting the inclusion criteria
- •Subjects being implanted with a multifocal IOL
- •Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
- •Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
- •Scheduled for surgery in the fellow eye within the study period
- •Have anterior chamber inflammation as measured by slit lamp examination at baseline. Anterior chamber cell and/or flare grade > 0
- •Have used any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to baseline visit
- •Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications
- •Be known corticosteroid intraocular pressure responder in either eye
- •Have used topical corticosteroid or NSAID treatment in either eye ≤ 48 hours prior to baseline visit
- •Systemic administration of corticosteroid within the past 14 days prior to baseline visit
- •Have received intravitreal, sub-Tenon's, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit
- •Have open wounds/ skin disease on the forehead area where the iontophoresis return electrode will be applied
- •Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
- •Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding the placement of the iontophoresis applicator
- •Have significant Fuch's Corneal Dystrophy
- •Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
- •Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin
- •Have optic neuritis of any origin
- •Have clinically suspected or confirmed central nervous system or ocular lymphoma
- •Have active hyphema, pars planitis, choroiditis, Behçet's disease, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
- •Have severe/serious ocular pathology or medical condition which may preclude study completion
- •History of HIV/AIDS
- •Have pacemaker and/or any other electrical sensitive support system
- •Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
- •Have participated in another investigational device or drug study within 30 days of baseline visit
- •Have already participated in this study
研究组 & 干预措施
Dexamethasone Phosphate Ophthalmic
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
干预措施: Dexamethasone Phosphate Ophthalmic (Drug)
100 mM Sodium Citrate Buffer
Placebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
干预措施: 100 mM Sodium Citrate Buffer (Drug)
结局指标
主要结局
Percentage of Subjects With AC Cell Count of Zero on Day 7
时间窗: At Day 7 (plus or minus two days) following the study treatment
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
次要结局
未报告次要终点