A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
- •Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
排除标准
- •Have any ocular/systemic health problems
- •Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.
研究组 & 干预措施
Brimonidine Tartrate
Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Brimonidine Tartrate (Drug)
Brimonidine Tartrate
Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Sodium Fluorescein (Drug)
Brimonidine Tartrate
Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP (Drug)
Brimonidine Tartrate Vehicle
Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Vehicle (Drug)
Brimonidine Tartrate Vehicle
Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Sodium Fluorescein (Drug)
Brimonidine Tartrate Vehicle
Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
干预措施: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to Day 29
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.
次要结局
- Drop Comfort Assessment as Assessed by the Participant(At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1)
- Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29(Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29)
