Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- SANDE Questionnaire
研究概览
简要总结
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
- •Subjects between the ages of 18-
- •Subjects willing to comply with the prescribed regimen and schedule of eye drops.
- •Subjects willing to attend all study visits.
- •Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Ocular anterior segment infection, inflammation, abnormality, or active disease.
- •History of herpetic keratitis or ocular surgery.
- •Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
- •Recent (within 1 year) blepharitis debridement procedure including BlephEx.
- •Screening SANDE score > 55 (equivalent to OSDI score of >32).2 This is indicative of a severe dry eye.
- •Screening SANDE score < 20 (equivalent to OSDI score of <12).2 This is indicative of a clinically normal eye.
- •Screening non-invasive TBUT < 2 seconds, or > 10 seconds.3
- •Screening NaFl score < 3 (clinically normal eye) or > 10 (severe dry eye).4
- •Pregnant or lactating.
- •Current use of contact lenses.
- •Any change in eye drop regimen, whether OTC or RX in the last 90 days.
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
研究组 & 干预措施
Systane Complete Multi-Dose PF
干预措施: Systane Complete Multi-Dose PF (Drug)
Walgreen's Lubricant Balance
干预措施: Walgreen's Lubricant Balance (Drug)
结局指标
主要结局
SANDE Questionnaire
时间窗: Change from baseline to 2 weeks
The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.
次要结局
未报告次要终点