ACTRN12621001737820已完成4 期
Changes in corneal epithelial irregularity following treatment with artificial tears in a symptomatic dry eye population
SW Sydney0 个研究点目标入组 50 人开始时间: 2021年12月20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
- 50
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
- •Aged 18 years or older;
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Minimum of 6 months since onset of self-reported dry eye;
- •Ocular Surface Disease Index score (OSDI) of >23 or Oxford Corneal Staining score 2 or 3 in at least one eye at Screening (Visit 1);
- •Not wearing soft contact lenses for 1 month prior to the study and for the duration of the study;
- •Willing to use the study eye drops four times daily for the duration of the study;
- •Been on stable dry eye treatment for at least 60 days prior to the study and willing to refrain from using any other topical eye drops apart from the study eye drops for the duration of the trial;
- •Willing to refrain from using warm compress treatments for dry eye for the duration of the trial;
- •Willing to refrain from using any eye drops on the same day as the first study visit, and within 2 hours of each study visit;
- •All prescription medications have been used consistently for at least 3 months prior to the study, and no planned changes for the duration of the trial;
- •No significant changes to diet implemented within 3 months prior to the first visit;
- •No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil);
- •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;
- •Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity;
- •Patients who are currently using topical ocular medication or have used topical ocular medication within 12 weeks of the first visit;
- •Any known allergy to the study eye drops;
- •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 corneal eye infection or any eye surgery;
- •Gas permeable contact lens wearer (including ortho-k) within 6 months of the first visit;
- •Pregnancy or breastfeeding.
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