A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining
研究概览
简要总结
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
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
- Single (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
- •Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
- •Age ≥ 18 years
- •Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- •Willing to sign a written informed consent to participate
- •Able to follow study instructions, with the intention of completing all required visits
排除标准
- •Presence of persistent corneal epithelial defect or ulcer in either eye
- •Presence of active ocular infection in either eye
- •Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
- •Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
- •Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
- •Contact lens wear
- •History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
- •Presence of cicatricial ocular surface diseases
- •A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
- •Any scheduled or planned ocular or systemic surgery or procedure during the study
- •Pregnancy and women who are expecting to be pregnant.
- •Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
研究组 & 干预措施
Treatment Arm
PROKERA SLIM + Standard of Care
干预措施: Self retained cryopreserved amniotic membrane (Device)
Treatment Arm
PROKERA SLIM + Standard of Care
干预措施: lifitegrast ophthalmic solution (Other)
Control Arm
Standard of Care
干预措施: lifitegrast ophthalmic solution (Other)
结局指标
主要结局
Corneal Fluorescein Staining
时间窗: 1 month
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
次要结局
- Ocular Surface Disease Index (OSDI)(1 month)
- Eye Dryness Score(1 month)