A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP) on Day 8
研究概览
简要总结
The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Written informed consent
- •At least 18 years of age
- •Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
- •Best corrected-distance visual acuity score equivalent to 20/80 or better
- •Stable visual field
- •Central corneal thickness between 490 - 620 micrometers
- •Inclusion Criteria at the Randomization Visit:
- •IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
- •Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
- •IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.
排除标准
- •Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
- •A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
- •Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
- •Cup-to-disc ratio of greater than 0.8
- •Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
- •Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
- •Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
- •Past history of any incisional surgery for glaucoma at any time
- •Past history of corneal refractive surgery
- •Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
- •Current participation in an investigational drug or device study or participation in such a study within 7 days of Screening
- •Inability to adequately evaluate the retina
- •Subjects who will require contact lens use during the study period.
- •Subjects who currently have punctal occlusion
- •Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
研究组 & 干预措施
Fixed Combination (FC) Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Fixed Combination (Drug)
Fixed Combination (FC) Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Placebo Segment (Device)
Fixed Combination (FC) Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Timolol 0.5% (Drug)
Bimatoprost Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Bimatoprost (Drug)
Bimatoprost Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Placebo Segment (Device)
Bimatoprost Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Timolol 0.5% (Drug)
Timolol Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Timolol (Drug)
Timolol Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Placebo Segment (Device)
Timolol Ocular Insert
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
干预措施: Timolol 0.5% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) on Day 8
时间窗: Day 8
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 16
时间窗: Day 16
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 28
时间窗: Day 28
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 49
时间窗: Day 49
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 70
时间窗: Day 70
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
次要结局
- Number of Participants With Ocular and Non-Ocular Adverse Events(From Randomization (Day 0) to Day 70)
- IOP During Open Label Period(Day 98, Day 112)