Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in anterior chamber inflammation (Cell and Flare) scores
研究概览
简要总结
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
详细描述
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes
- •Are willing and able to comply with clinic visits and study related procedures
- •Are willing and able to sign the informed consent form
排除标准
- •Under the age of 18 at the time of signing the Informed Consent Form
- •Pregnant or planning to become pregnant during the trial period
- •Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
- •Have active infectious systemic disease
- •Have active infectious ocular or extraocular disease
- •Have punctal plug in the study eye
- •Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
- •Have known hypersensitivity to dexamethasone or are a known steroid responder
- •Have a history of ocular inflammation or macular edema
- •Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
- •Are currently being treated with immunomodulating agents in the study eye
- •Are currently being treated with immunosuppressants and/or oral steroids
- •Are currently being treated with corticosteroid implant (i.e Ozurdex)
- •Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
- •Have a history of complete punctal occlusion in one or both punctum
- •Currently using topical ophthalmic steroid medications
- •Are unwilling or unable to comply with the study protocol
- •Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
研究组 & 干预措施
Arm 1 - Cataract surgery gtt regimen per SOC
Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.
干预措施: Prolensa 0.07% Ophthalmic Solution (Drug)
Arm 1 - Cataract surgery gtt regimen per SOC
Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop
干预措施: Prolensa 0.07% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean change in anterior chamber inflammation (Cell and Flare) scores
时间窗: Assessed on Days 1,7,30,90
Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.
Mean change in pain score
时间窗: Assessed on Day 1,7, 30 and 90
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe.
次要结局
- Visual outcome (Best Corrected Visual Acuity)(Assessed on Day 1,7, 30 and 90)
- Absence of CME (Cystoid Macular Edema)(Assessed on Day 90)
- Mean change in corneal staining(Assessed on Day 7, 30 and 90)
研究者
Nicole Fram M.D.
CEO
Advanced Vision Care