NCT04944290已完成3 期
Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide/Brimonidine Ophthalmic Suspension 1% to Simbrinza® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 447
- 试验地点
- 1
- 主要终点
- Mean Change in Intra-ocular Pressure
研究概览
简要总结
To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
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
- •Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
- •Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- •Adequate wash-out period prior to baseline of any ocular hypotensive medication.
- •Baseline (Day 0/hour 0) pressure ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm Hg.
- •Baseline best corrected visual acuity equivalent to 20/200 or better in each eye
排除标准
- •Females who are pregnant, breast feeding, or planning a pregnancy.
- •Females of childbearing potential who do not agree to utilize an adequate form of contraception
- •Current, or past history of, severe hepatic or renal impairment
- •Current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye
- •Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer
- •Functionally significant visual field loss
- •Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
- •Use at any time prior to baseline of an intraocular corticosteroid implant
- •Use within one week prior to baseline of contact lens
- •Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
- •Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy
- •Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
- •Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
- •Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction
研究组 & 干预措施
Perrigo active
Experimental
干预措施: Brinzolamide/brimonidine ophthalmic suspension (Drug)
Reference active
Active Comparator
干预措施: Simbrinza 0.2%/1% Ophthalmic Suspension (Drug)
结局指标
主要结局
Mean Change in Intra-ocular Pressure
时间窗: 6 weeks
mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement
次要结局
未报告次要终点
研究者
研究点 (1)
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