A Phase 1/2a, Randomized, Parallel-group, Double-masked, Vehicle-controlled, Dose-frequency Escalation Study to Evaluate the Safety, Tolerability, and Intraocular Pressure (IOP)-Lowering Efficacy of Topically Administered LX7101 in Subjects Diagnosed With Primary Open-angle Glaucoma (POAG) or Ocular Hypertension (OHT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing an adverse event
研究概览
简要总结
This Phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adults ≥18 years of age
- •Documented diagnosis of POAG or OHT, in both eyes
- •Willing and able to provide written informed consent
排除标准
- •History of any form of glaucoma in either eye, other than POAG
- •Subjects who are unwilling or unable to discontinue contact lens wear prior to and during study
- •History of ocular trauma in either eye <6 months prior to Screening
- •History of ocular infection or ocular inflammation in either eye <3 months prior to Screening
- •History of chronic or recurrent severe inflammatory eye disease, any severe ocular pathology, or clinically relevant or progressive retinal diseases in either eye
- •Clinically relevant, severe central visual field loss, or documented significant progression of a visual field defect within 6 months prior to Screening in either eye
- •Use of any ocular hypertensive medications (if applicable), in either eye, during the washout period and for the duration of the study
- •Use of any glucocorticoid medications <2 weeks prior to Screening and throughout the duration of the study
- •Use of any medication or substance on a chronic basis which has not been taken at a stable dose for at least 30 days prior to Screening
- •Use of any nondiagnostic, topical, ophthalmic preparations, in either eye, other than artificial tears
- •The presence of any concurrent condition or clinically significant laboratory findings at Screening that may interfere with any aspect of safety, study conduct, or interpretation of results
- •Women who are pregnant or breast feeding
- •Inability or difficulty instilling eye drops
研究组 & 干预措施
Low dose LX7101
Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)
干预措施: LX7101 (0.125%) (Drug)
High dose LX7101
Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)
干预措施: LX7101 (0.25%) (Drug)
LX7101 Vehicle
Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)
干预措施: LX7101 Vehicle (Drug)
结局指标
主要结局
Number of subjects experiencing an adverse event
时间窗: 15 Days
次要结局
- Mean Intraocular Pressure (IOP) in the study eye(Days 1, 3, 7, 10, 14, 15)
- Best Corrected Visual Acuity (BCVA)(Days 1, 3, 7, 10, 14, 15)
- Slit lamp biomicroscopy exam (SLE)(Days 1, 3, 7, 10, 14, 15)