Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 主要终点
- Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
研究概览
简要总结
The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.
详细描述
This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.
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
- Single (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 BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).
- •At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.
- •Use provided artificial tear at least once a week during run-in phase.
- •Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Use of artificial tears, as specified in the protocol.
- •Use of topical ocular medications, as specified in the protocol.
- •Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
- •Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.
- •Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.
- •Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.
- •Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.
- •Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Systane Ultra QID
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
干预措施: SYSTANE® ULTRA Lubricant Eye Drops (Drug)
Systane Ultra PRN
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
干预措施: SYSTANE® ULTRA Lubricant Eye Drops (Drug)
结局指标
主要结局
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
时间窗: Baseline (Day 0), Day 28
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
次要结局
- Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28(Baseline (Day 0), Day 28)
- Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28(Baseline (Day 0), Day 28)