Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Ocular Itching at Baseline (Day 0)
研究概览
简要总结
To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.
详细描述
Structure:
Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:
- Prednisolone Acetate 1% ophthalmic suspension
- Prednisolone Acetate 0.12% ophthalmic suspension
- Loteprednol Etabonate 0.2% ophthalmic suspension
- Tears Naturale® II
Duration:
Approximately four (4) weeks
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
- 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
- •At least 18 years of age & either sex, any race
- •Willing and able to follow all instructions
- •Positive history of ocular allergies
- •Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
排除标准
- •Have planned surgery during trial period
- •Female currently pregnant, planning a pregnancy or lactating
- •Use of disallowed medications
- •Have ocular infections, or ocular conditions that could affect study parameters
- •Have moderate to severe dry eye
- •Have used an investigational drug or device within 30 days of start of study
- •Female that is currently pregnant, planning a pregnancy or lactating
研究组 & 干预措施
Pred acetate 1%
Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
干预措施: Prednisolone Acetate 1% (Drug)
Pred acetate .12%
Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
干预措施: Prednisolone Acetate 0.12% (Drug)
Lot Etab 0.2%
Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
干预措施: Loteprednol Etabonate 0.2% (Drug)
Placebo
Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Itching at Baseline (Day 0)
时间窗: 3, 5, 7 minutes post-CAC
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 6
时间窗: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 7
时间窗: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 27
时间窗: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Day 28
时间窗: 3, 5, 7 minutes post-CAC
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Redness at Baseline (Day 0)
时间窗: 7, 15, 20 minutes post-CAC
A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 6
时间窗: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 7
时间窗: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 27
时间窗: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Ocular Redness at Day 28
时间窗: 7, 15, 20 minutes post-CAC
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
次要结局
未报告次要终点