Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 4
- 主要终点
- OSDI Scores
研究概览
简要总结
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults>=18 years of age
- •Corrected visual acuity of 20/100 or better in both eyes
- •Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive]
- •Tear break up time score of <=5 seconds in both eyes
- •Schirmer I test (without anesthesia) >=5 mm in both eyes
排除标准
- •Discontinue contact lens wear starting 7 days prior and throughout the study
- •Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study
- •Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome)
- •History of ocular surgery within the past 12 months
- •History of severe ocular trauma, active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications.
- •Women who are pregnant or breast feeding(self report)
- •Subjects with a condition or in a situation, which in the investigator's opinion, may put the subject at significant rist, may confound the study results, or may significantly interfere with their participation in the study
- •Subjects will not be allowed to use any other topical eye drops or other dry eye treatments beyond their assignment during the study
- •Participants in clinical trial or study using a device, topical, or oral therapeutic in the past 3 months of enrollment
研究组 & 干预措施
MIEBO™ (Perfluorohexyloctane, PFHO)
Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.
干预措施: MIEBO™ (Perfluorohexyloctane, PFHO) (Drug)
SYSTANE® PRO
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
干预措施: SYSTANE® PRO (Drug)
结局指标
主要结局
OSDI Scores
时间窗: Between group difference at 1 month
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).
次要结局
- Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit(Between-group difference in mean change from baseline at 1 month)
- Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit(Between-group difference in mean change from baseline at 2 weeks)
研究者
Anna Tichenor
Principal Investigator
Indiana University