Multi-Center, Double-Masked, Randomized, Placebo-Controlled Phase 2b Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Having Undergone Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens (IOL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Pain score = 0
研究概览
简要总结
Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).
详细描述
This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The study has 2 different treatment arms consisting of the following iontophoresis treatment regimen:
Treatment Arm 1, up to 50 subjects will receive the following study treatment:
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
Treatment Arm 2, up to 50 subjects will receive the following study treatment:
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
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)
盲法说明
Sponsor, investigator, subject will all be masked to study treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（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)
- •Age 18 to 85 years
- •Receive, understand, and sign a copy of the written informed consent form (ICF)
- •Are able to return for all study visits and willing to comply with all study-related instructions
排除标准
- •Are undergoing implantation of a multifocal and/or depth enhancing IOL
- •Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
- •The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
- •Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
- •Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
- •Have undergone cataract surgery in the fellow eye within 4 weeks prior to baseline visit (Day 0) and still require post-operative medications in that fellow eye
- •Are scheduled for surgery in the fellow eye within the study period
- •Have anterior chamber inflammation as measured by slit lamp examination in the study eye at the baseline visit (Day 0) [Defined as anterior chamber (AC) cell and/or flare grade > 0]
- •Have history of uveitis or inflammatory disease in the study eye
- •Requires simultaneous supplemental surgery, such as glaucoma procedures or vitrectomy, in the study eye
- •Have used any topical ocular medication in either eye, other than tear substitute for dry eye, within the past 2 weeks prior to baseline visit (Day 0)
- •Have used topical corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) treatment in either eye < 48 hours prior to the baseline visit (Day 0) (excluding the use of topical NSAIDs, pre-operatively on Day 0 and administered at the clinic site under the investigator's oversight)
- •Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, and/or require ocular anti-hypertensive medications
- •Are known corticosteroid IOP responder in study eye
- •Have received systemic administration of corticosteroid and/or immunosuppressants within the past 14 days prior to baseline visit (Day 0)
- •Have received intravitreal, sub-Tenon, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit (Day 0)
- •Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
- •Have lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
- •Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding placement of the iontophoresis applicator
- •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 that could be worsened with steroid use
- •Have optic neuritis of any origin
- •Have clinically suspected or confirmed central nervous system or ocular lymphoma
- •Have active hyphema, pars planitis, choroiditis, toxoplasmosis scar, vitreous hemorrhage, and/or clinically significant macular edema (CSME) that would compromise visual acuity recovery
- •Have severe/serious ocular pathology or medical condition which may preclude study completion
- •Have pacemaker and/or any other electrical sensitive support system
- •Are 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 (Day 0) (other clinical trial participation while participating in EGP-437-009 would be prohibited per protocol)
- •Have previously participated in a study with EGP-437
研究组 & 干预措施
Placebo
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
干预措施: Placebo (Other)
EGP-437
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
干预措施: Dexamethasone phosphate (Combination Product)
结局指标
主要结局
Pain score = 0
时间窗: 1 day post-surgery and following first study treatment
The proportion of subjects with a pain score of zero on Day 1
AC cell count = 0
时间窗: 7 days' following first study treatment
The proportion of subjects with an AC cell count of zero on Day 7
次要结局
未报告次要终点