NCT01302249已完成2 期
A Phase 2, Double-masked, Randomized, Active-controlled, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost
Aerie Pharmaceuticals15 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011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
- 66
- 试验地点
- 15
- 主要终点
- Intraocular pressure
研究概览
简要总结
This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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).
- •Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
- •Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
- •Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
- •Able and willing to give signed informed consent and follow study instructions
排除标准
- •In either eye:
- •Previously randomized to treatment in a clinical study of AR-
- •Intraocular pressure > 36 mm Hg.
- •History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
- •Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
- •Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
- •Contact lens wear within 30 minutes of instillation of study medication.
- •PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).
- •Conjunctival hyperemia of grade 2+ or greater at Visit
- •Any other ocular medication within 4 weeks of Visit 1 with the exception of 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 treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
- •Any abnormality preventing reliable applanation tonometry of either eye.
- •In study eye(s):
- •Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- •Previous glaucoma intraocular surgery or laser procedures.
- •Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Central corneal thickness greater than 600 µ.
- •Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure.
- •Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
- •Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine 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 4 weeks prior to screening, or anticipated during the study.
- •Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
研究组 & 干预措施
AR-12286
Experimental
AR-12286 Ophthalmic Solution 0.5%
干预措施: Latanoprost 0.005% (Drug)
AR-12286
Experimental
AR-12286 Ophthalmic Solution 0.5%
干预措施: AR-12286 Ophthalmic Solution 0.5% (Drug)
Timolol
Active Comparator
Timolol maleate ophthalmic solution 0.5%
干预措施: Latanoprost 0.005% (Drug)
Timolol
Active Comparator
Timolol maleate ophthalmic solution 0.5%
干预措施: Timolol maleate ophthalmic solution 0.5% (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 28 days
The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.
次要结局
- Ocular safety(28 days)
- Systemic safety(28 days)
研究者
研究点 (15)
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