ACTRN12619000275167已完成4 期
The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye population
SW Sydney0 个研究点目标入组 39 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Adults aged 18 years and over with symptoms of dry eye;
- •Ocular Surface Disease Index score of greater than 12 at Screening (Visit 1);
- •Average lipid layer thickness less than or equal to 75nm in at least one eye at Screening;
- •Not wearing contact lenses for 1 month prior to the study and for the duration of the study;
- •Willing to use the study eye drops and refrain from using any other eye drops for the duration of the study;
- •Willing to refrain from using the study eye drops within 4 hours prior to each study visit;
- •Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator.
排除标准
- •Any active anterior segment disease excluding blepharitis;
- •Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
- •Ocular medication, category S3 and above;
- •Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine.
- •Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) for less than 12 weeks prior to the start of the study;
- •Planned changes to intake of polyunsaturated fatty acid-containing dietary supplements and/or diet (including typical intake of fish) for the duration of the study;
- •Use of any at-home eyelid warming treatments for less than 12 weeks prior to the start of the study, or planned changes to routine usage over the course of the study;
- •Use of any of the following dry eye treatments up to 6 months prior to the start of the study or during the course of the study:
- •oIntense Pulsed Light (IPL) therapy;
- •oBlephasteam;
- •oLipiFlow Thermal Pulsation treatment;
- •oPunctal plugs.
- •Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
- •History of eye surgery within 6 months prior to enrolment in the study;
- •Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
- •Any known allergy to the ingredients in Systane Complete;
- •Pregnancy or breastfeeding.
研究者
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