A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Peak discomfort score over a 3-minute period after drop instillation
研究概览
简要总结
The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
详细描述
In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
- •Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
- •History of any clinically significant external ocular disease within 30 days of the start of the study.
- •Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Olopatadine, 0.7%
Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.7% (Drug)
Olopatadine, 0.7%
Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution vehicle (Drug)
Olopatadine, 0.7%
Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Ketotifen fumarate ophthalmic solution, 0.025% (Drug)
Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.7% (Drug)
Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution vehicle (Drug)
Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
干预措施: Ketotifen fumarate ophthalmic solution, 0.025% (Drug)
Zaditor
Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.7% (Drug)
Zaditor
Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized
干预措施: Olopatadine hydrochloride ophthalmic solution vehicle (Drug)
Zaditor
Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized
干预措施: Ketotifen fumarate ophthalmic solution, 0.025% (Drug)
结局指标
主要结局
Peak discomfort score over a 3-minute period after drop instillation
时间窗: Up to Day 3
Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.
次要结局
- Product Acceptability(Up to Day 3)
- Ocular Symptoms(Up to Day 3)