Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Immunologic Rejection
研究概览
简要总结
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •o At least 18 years of age
- •Male or female patient who had DMEK within the past 1 to 7 weeks.
- •Patient is able and willing to administer eye drops.
- •Patient is able to comprehend and has signed the Informed Consent form.
- •Patient is likely to complete the 11-month study duration.
排除标准
- •o A history of a previous rejection episode in the study eye
- •A patient exhibiting intraocular inflammation.
- •A patient with a known sensitivity to any of the ingredients in the study medications
- •A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- •A patient with abnormal eyelid function.
- •A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
- •Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
- •A patient with a history of non-compliance with using prescribed medication.
- •Patients who are pregnant or planning to become pregnant within the duration of the study
研究组 & 干预措施
Preventative Treatment
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
干预措施: loteprednol etabonate 0.25% ophthalmic suspension (Drug)
结局指标
主要结局
Immunologic Rejection
时间窗: 11 months
incidence of immunologic rejection episodes
Steroid-induced Ocular Hypertension
时间窗: 11 months
incidence of steroid-induced ocular hypertension
次要结局
未报告次要终点