Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
研究概览
简要总结
The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.
详细描述
Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.
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
- •Willing and able to attend all study visits;
- •Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;
- •Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant or breast feeding;
- •Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;
- •Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;
- •Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;
- •Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;
- •History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit;
- •Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study;
- •Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit;
- •Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study;
- •Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
SYSTANE HYDRATION
SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
干预措施: SYSTANE HYDRATION lubricant eye drops (Device)
SYSTANE HYDRATION
SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
干预措施: 0.9% saline eye drops (Drug)
Hyabak 0.15%
Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
干预措施: Hyabak 0.15% eye drops (Device)
Hyabak 0.15%
Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
干预措施: 0.9% saline eye drops (Drug)
结局指标
主要结局
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
时间窗: Baseline (Day 0), Day 42
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.
次要结局
- Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42(Baseline (Day 0), Day 42)
- Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42(Baseline (Day 0), Day 42)
- Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42(Baseline (Day 0), Day 42)