Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Ocular Itching
研究概览
简要总结
The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form and HIPAA document
- •Willing and able to comply with all study procedures
- •Be at least 10 years of age at the time of enrollment
- •LogMar 0.7 or better, in each eye
- •History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
- •A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
排除标准
- •have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
- •have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye);
- •have a current diagnosis or history of open angle glaucoma or ocular hypertension;
- •have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months;
- •have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
- •have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
- •manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study
- •have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
研究组 & 干预措施
SPARC1102 I
1334H 0.15% eye drops will be administered in both eyes at 3 occasions
干预措施: SPARC1102 I (Drug)
SPARC1102 II
1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
干预措施: SPARC1102 II (Drug)
SPARC1102 III
1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
干预措施: SPARC1102 III (Drug)
Vehicle
Placebo eye drops (solution)will be administered in both eyes at 3 occasions
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular Itching
时间窗: Up to 28 days
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.
次要结局
- Ciliary Redness Evaluated by the Investigator(Up to 4 weeks)