A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 主要终点
- Corneal Epithelial Damage
研究概览
简要总结
To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
详细描述
Dry Eye Disease (DED) is a chronic, progressive inflammatory multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED creates a vicious cycle of ocular surface inflammation and damage. Beyond simple 'dryness', DED is recognized as a chronic, potentially progressive condition that can lead to significant visual impairment, corneal scarring, and a diminished quality of life (QoL) comparable to moderate-to-severe angina or dialysis.
While standard therapies (lubricants, anti-inflammatory agents) manage symptoms, many patients suffer from refractory epithelial defects and keratitis. Human Amniotic Membrane (HAM) has been shown to possess anti-inflammatory, anti-scarring, and epithelial-promoting properties. The Human Amniotic Membrane (HAM) is the innermost layer of the placenta. It is uniquely suited for ocular surface reconstruction due to its complex biological scaffold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •18 years of age or older.
- •Corneal Fluorescein Staining (CFS) Modified NEI grade > 15 in the study eye.
- •Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
- •Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.
- •Participant must be able to follow study instructions, with the intention of completing all required visits
- •Participant must agree to attend the study visits required by the protocol.
- •Participant must be able and willing to complete follow-up.
- •Participant must be willing and able to participate in the informed consent process.
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
- •History of procedures listed in 6.7.1 within the specified washout period
- •CONFIDENTIAL
- •Version No. 1 Version Date 06APR2026
- •Page PAGE 67 of NUMPAGES 67
- •VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026
- •History or use of any medications listed in 6.7.2 within the specified washout period
- •Ophthalmic use of amniotic membrane in the past 90 days.
- •Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
- •Medical or psychological condition that, in the opinion of the investigator, may interfere with study.
- •Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- •Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
研究组 & 干预措施
FD-AM + SoC
Participants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).
干预措施: Standard of Care (SOC) (Procedure)
Standard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).
干预措施: Lyophilized Amnion Membrane Disc Allograft (Other)
FD-AM + SoC
Participants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).
干预措施: Lyophilized Amnion Membrane Disc Allograft (Other)
结局指标
主要结局
Corneal Epithelial Damage
时间窗: 6-8 weeks
Evaluate the change of corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.
次要结局
- Stability of Tear Film(6-8 weeks)
- Patient Reported Symptoms(6-8 weeks)