Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 20
- 主要终点
- Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
研究概览
简要总结
This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated IOP due to OAG or OHT.
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
- •Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable)
- •Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowering eyedrop
- •IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit
- •Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥ 22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.
排除标准
- •Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments
- •Pseudoexfoliation or pigment dispersion component glaucoma
- •History of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening
- •Intraocular pressure ≥ 36 mmHg
- •Cup/disc ratio of > 0.8 in either eye
- •Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10 degrees of fixation in either eye
研究组 & 干预措施
AKB-9778 4% QD + Latanoprost
• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
干预措施: Latanoprost ophthalmic solution (Drug)
AKB-9778 4% QD + Latanoprost
• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
干预措施: AKB-9778 4% (Drug)
AKB-9778 4% BID + Latanoprost
• AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
干预措施: Latanoprost ophthalmic solution (Drug)
AKB-9778 4% BID + Latanoprost
• AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
干预措施: AKB-9778 4% (Drug)
Placebo Twice Daily + Latanoprost
• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
干预措施: Latanoprost ophthalmic solution (Drug)
Placebo Twice Daily + Latanoprost
• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
时间窗: Baseline to Day 28
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
次要结局
- Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)(Baseline to Day 14 and Baseline to Day 28)
- Mean Observed IOP at Each Time Point on Days 14 and 28(Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28)
- Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28(Baseline to Day 14 and Baseline to Day 28)
- Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)(Baseline to Day 14 and Baseline to Day 28)
- Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)(Baseline to Day 14)
- Mean Change From Baseline IOP at Each Time Point on Days 14 and 28(Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28)
- Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28(Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28)
- Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels(Baseline to Day 28)