NCT01060579已完成2 期
A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure
Aerie Pharmaceuticals18 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 18
- 主要终点
- The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
研究概览
简要总结
A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or greater.
- •Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
- •Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
- •Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
- •Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
- •Able and willing to give signed informed consent and follow study instructions.
排除标准
- •Ophthalmic (in either eye):
- •Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- •Intraocular pressure > 36 mm Hg
- •Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- •Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
- •Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
- •History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
- •Contact lens wear within 30 minutes of instillation of study medication.
- •Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
- •Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio > 0.8).
- •Central corneal thickness greater than 600 μ.
- •Any abnormality preventing reliable applanation tonometry of either eye.
- •Clinically significant abnormalities in laboratory tests at screening.
- •Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- •Participation in any investigational study within the past 30 days.
- •Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
- •Due to status of preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
研究组 & 干预措施
AR-12286 0.5% ophthalmic solution
Experimental
干预措施: AR-12286 0.5% ophthalmic solution (Drug)
AR-12286 0.25% Ophthalmic Solution
Experimental
干预措施: AR-12286 0.25% Ophthalmic solution (Drug)
Latanoprost 0.005% ophthalmic solution
Experimental
干预措施: Latanoprost ophthalmic solution (Drug)
结局指标
主要结局
The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
时间窗: 28 days of dosing
次要结局
- Mean change from diurnally adjusted baseline IOP at each timepoint(28 days of dosing)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 MonthsOpen-angle GlaucomaOcular HypertensionNCT01699464Aerie Pharmaceuticals211
已完成
2 期
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAGPrimary Open-Angle Glaucoma (POAG)Ocular Hypertension (OHT)NCT02829996Inotek Pharmaceuticals Corporation201
已完成
2 期
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular HypertensionPrimary Open Angle Glaucoma or Ocular HypertensionNCT03310580Aerie Pharmaceuticals42
已完成
2 期
Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)Diabetic Macular EdemaNCT06099184EyePoint Pharmaceuticals, Inc.27
已完成
2 期
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)Nonproliferative Diabetic RetinopathyNCT05383209EyePoint Pharmaceuticals, Inc.77