Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- Change From Baseline in TFBUT at Day 35
研究概览
简要总结
The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.
详细描述
This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.
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 (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
- •Must have all of the following in at least 1 eye at Screening:
- •Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
- •The average of 3 measures of TFBUT ≤ 5 seconds, and
- •Unanesthetized Schirmer I test of ≥ 3 mm.
- •Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day).
- •Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method).
- •Physician diagnosis of dry eye at least 6 months prior to Screening visit.
- •Willing and able to attend all study visits.
- •Must sign a written informed consent form.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening.
- •Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening.
- •Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening.
- •Women of childbearing potential are excluded from participating in this study if they met any of the following conditions:
- •Currently pregnant, or
- •Test positive for pregnancy at Screening visit, or
- •Currently breast feeding, or
- •Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products.
- •Has an active ocular allergy.
- •Any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc.
- •Subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study.
- •History of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of Screening.
- •Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc.
- •Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening.
- •Any significant illnesses that could be expected to interfere with the study parameters.
- •Subjects with active oculodermal rosacea with meibomian gland dysfunction.
- •Participation in an investigational drug or device trial within 30 days of Screening.
- •Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study.
- •Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Systane Balance
Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).
干预措施: Propylene Glycol, 0.6% eye drops (Drug)
Saline
Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).
干预措施: Preservative-free 0.9% Saline solution (Drug)
结局指标
主要结局
Change From Baseline in TFBUT at Day 35
时间窗: Baseline (Day 0), Day 35
TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.
次要结局
- Change From Baseline in TOSS Score at Day 35(Baseline (Day 0), Day 35)
- Change From Baseline in OSDI Score at Day 35(Baseline (Day 0), Day 35)
- Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35(Baseline (Day 0), Day 35)
- Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35(Baseline (Day 0), Day 35)