NCT01698814已完成3 期
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily
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
- 518
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, 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
- •Able and willing to comply with study protocol and follow protocol instructions.
- •Adequate birth control methods for the duration of the study.
- •Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
- •Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
- •Willing and able to sign an Informed Consent form.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
- •Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit
- •Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit
- •Current or past history of glaucoma or ocular hypertension.
- •History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
- •Presence of ocular conditions that may affect the study outcomes.
- •Corneal conditions affecting the corneal structure.
- •History or evidence of any ocular surgical procedure within 1 year prior to Visit
- •Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
- •Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
- •Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
- •Known contraindications or hypersensitivities to any of the study medications or their components.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
AL-4943A
Experimental
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
干预措施: AL-4943A Ophthalmic Solution (Drug)
AL-4943A Vehicle
Placebo Comparator
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
干预措施: AL-4943A Ophthalmic Solution Vehicle (Drug)
结局指标
主要结局
Adverse Events
时间窗: An average of 6 weeks
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
次要结局
未报告次要终点
研究者
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