A Phase I, Multi-Center, Randomized, Adaptive, Investigator/Patient Masked, Multiple-Ascending Dose, Placebo and Active Comparator-Controlled Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Topical Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 8
- 主要终点
- Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
研究概览
简要总结
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 90 years of age inclusive, at the time of signing the informed consent form
- •Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening
- •Treatment-naïve participants or participants who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
- •At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
- •Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
- •Central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening
- •Cup-to-disc ratio ≤ 0.8 (both eyes) at screening
- •Anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening
排除标准
- •Advanced visual field defects
- •Other forms of glaucoma than POAG or OHT
- •Any abnormality preventing reliable applanation tonometry
- •Any clinically significant corneal scarring, haze or opacity
- •Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
- •Any presence or history of uveitis or other history of any ocular inflammatory disease.
- •History or signs of penetrating ocular trauma
- •Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment
- •History of any glaucoma surgery
- •History of refractive surgery
- •Any other intra-ocular surgery within six months of screening
- •Any active ocular disease requiring treatment.
- •Use of any listed prohibited medications
- •Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research
- •Any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol
研究组 & 干预措施
1% RO7058584 or Matching Placebo
干预措施: Matching Placebo (Drug)
0.01% RO7058584 or Matching Placebo
干预措施: 0.01% RO7058584 (Drug)
0.01% RO7058584 or Matching Placebo
干预措施: Matching Placebo (Drug)
0.1% RO7058584 or Matching Placebo
干预措施: 0.1% RO7058584 (Drug)
0.1% RO7058584 or Matching Placebo
干预措施: Matching Placebo (Drug)
1% RO7058584 or Matching Placebo
干预措施: 1% RO7058584 (Drug)
RO7058584 and Latanoprost 0.005%
干预措施: 0.01% RO7058584 (Drug)
RO7058584 and Latanoprost 0.005%
干预措施: 0.1% RO7058584 (Drug)
RO7058584 and Latanoprost 0.005%
干预措施: 1% RO7058584 (Drug)
RO7058584 and Latanoprost 0.005%
干预措施: Latanoprost 0.005% (Drug)
结局指标
主要结局
Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
时间窗: Up to 12 weeks
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of Blood Pressure Abnormalities
时间窗: Up to 12 weeks
Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration
时间窗: 7 days
IOP will be assessed by Goldman Applanation tonometry.
Incidence of Electrocardiogram (ECG) Findings
时间窗: Up to 12 weeks
Incidence of Pulse Rate Abnormalities
时间窗: Up to 12 weeks
Incidence of Abnormal Laboratory Findings
时间窗: Up to 12 weeks
次要结局
- Cmax of RO7058584(Up to Day 8)
- Ctrough of RO7058584(Up to Day 8)
- AUC0-24h of RO7058584(Up to Day 8)
- Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration(7 days)
- Tmax of RO7058584(Up to Day 8)