A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 806
- 试验地点
- 50
- 主要终点
- Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
研究概览
简要总结
This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ocular hypertension or glaucoma in each eye
- •Requires intraocular pressure (IOP)-lowering therapy in both eyes
- •Best corrected visual acuity of 20/100 or better in each eye
排除标准
- •Ocular seasonal allergies within 2 years
- •Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
- •Ocular surgery or laser within 3 months
- •Anticipated wearing of contact lenses during the study
研究组 & 干预措施
Bimatoprost 0.01% Ophthalmic Solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
干预措施: bimatoprost 0.01% ophthalmic solution (Drug)
Bimatoprost 0.03% Ophthalmic Solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
干预措施: bimatoprost 0.03% ophthalmic solution (Drug)
结局指标
主要结局
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
时间窗: 24 Months
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
次要结局
- Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"(24 Months)