CTIS2022-502643-35-00招募中1 期
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12 Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy - K-321-303
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Is at least 18 years old at the screening visit (Visit 1), Has a diagnosis of FECD at Visit 1, Has confluent central guttae in the study eye that can be removed by descemetorhexis of a circular area of 5.5 mm diameter or less (at Visit 1), Study eye with BCVA of 75 letters or fewer by ETDRS testing (Snellen equivalent of 20/32 or worse) at Visit 1, Has a visually significant cataract in the study eye at Visit 1, Can understand the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements before any study-specific assessments are performed., The study eye descemetorhexis at Visit 2 is confirmed to have excised a central area with confluent guttae and a diameter of 4.5 to 5.5 mm., Completion of cataract surgery and with the following conditions: a. Intraocular lens placement in the capsular bag without complications (eg, broken posterior capsule, need for anterior vitrectomy). b. Absence of Descemet membrane stripping or detachment outside the central zone (a small area of detachment or stripping may occur adjacent to the phaco wound and is acceptable if =0.5mm surface area). c. Confirmation via the operating microscope that the intraocular lens is in the correct location in the capsular bag. d. No AE noted by the surgeon during the surgery.
排除标准
- •Is a female subject of childbearing potential and any of the following is true: a. is pregnant or lactating/breastfeeding, or b. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy), Has a study eye with central corneal thickness = 670 µm at Visit 1, Has known severe comorbidities that may interfere with simultaneous cataract surgery and descemetorhexis (including but not limited to a bacterial, viral, or fungal ophthalmic infection), Has any clinically significant ocular condition, other than FECD, cataract, primary open-angle glaucoma* or dry eye in the study eye that requires medication or ocular surgery, Has diabetes with poor blood sugar control, defined as hemoglobin A1c (HbA1c) value >8.5% at Visit 1, Has used either collagen shield or contact lenses in either one eye or both eyes within 7 days of Visit 1, Is unwilling to stop use of either collagen shield or contact lenses for the duration of the study, Has hypersensitivity to any ophthalmic medication used for diagnosis or treatment, including eye drops containing antibiotic(s) or glucocorticoid(s), Has known hypersensitivity to any component of the study drugs, Has previously used ripasudil, Has used netarsudil or eye drops and ointments containing =2% sodium chloride within 14 days prior to Visit 1, Has a study eye with confluent guttae in the periphery or confluent guttae outside the stripped area (individual guttae are allowed) after simultaneous cataract surgery and descemetorhexis, Has partecipated in any investigational drug or device clinical studies within 30 days of Visit 1 or is planning to participate in any investigational drug or device clinical studies during the study period, Has a positive urine test result for drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates, or benzodiazepines) or alcohol at screening; however, drugs prescribed to treat current medical conditions are allowed, Is a member or a family member of the professional or ancillary personnel working at the study site or the Sponsor involved in the study, Has a concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the Investigator, Is using any prohibited prescription or over-the-counter (OTC) medications or devices and is unwilling or unable to discontinue these medications or devices for the required time period before entry into the study, Is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, Has any ocular disease that may affect visual acuity in the study eye, such as glaucoma that has progressed to the central visual field, age-related macular degeneration, diabetic macular edema, amblyopia, etc, Has had capsular rupture or infection in the study eye or any other complications or AEs during cataract surgery., Has a study eye with baseline (pre-DSO) peripheral ECD ungradable for any area (nasal, temporal, superior, and inferior) due to any reason other than a medical reason (eg, guttae, corneal edema, or striae), Has a study eye with a history of any previous intraocular surgery other than for cataract prior to Visit 1, Has a non-study eye wit
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