NCT01159015已完成3 期
A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 534
- 主要终点
- Percentage of Participants With at Least One Adverse Event.
研究概览
简要总结
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects less than 18 years of age, have either a history or family history of ocular allergy.
- •ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.
排除标准
- •Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
- •Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit
- •Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
- •A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- •An active ocular infection (bacterial, viral or fungal
- •Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
- •Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
- •Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
- •Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
研究组 & 干预措施
KetoNaph
Experimental
KetoNaph Ophthalmic Solution
干预措施: KetoNaph (Drug)
Vehicle
Placebo Comparator
Vehicle of KetoNaph Ophthalmic Solution
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Adverse Event.
时间窗: 42 days
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
次要结局
未报告次要终点
研究者
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