ACTRN12621000336886已完成未知
Effect on tear film properties and dry eye signs and symptoms of having an adjunctive treatment of treatments of Optimel Manuka Dry Eye Drops with the Bruder Eye Compress compared with Optimel Manuka Dry Eye Drops alone after four weeks of daily use in adults
SW Sydney0 个研究点目标入组 34 人开始时间: 2021年3月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 34
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;
- •General population aged 18 years and over;
- •In good general health;
- •Subjectively experiencing dry eye symptoms (e.g. burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun). Participants will be selected based on a minimum OSDI score of 13 points.
- •Have not used Optimel Manuka+ Dry Eye Drops in the past 3 months
- •Have not used warm compresses or lid scrubs in the past 1 month
- •Participant is willing to discontinue their current use of any rewetting/lubricating drops 3 days before the study and throughout the study;
- •Willing to comply with the dosage and study visit schedule as directed by the investigator;
- •Willing to notify the study investigator if instructed to alter their dietary intake of fish or omega-3 supplements by health/medical practitioner;
排除标准
- •Allergy to benzoic acid preservatives;
- •Allergy to honey products;
- •Active anterior eye disease/ infection, inflammation/allergy that requires ocular medical treatment;
- •Eye injury or surgery in the past 6 months including chemical burns, penetrating injuries, traumatic iritis, orbital fractures, laser surgery, strabismus surgery, cataract or any other intraocular surgeries;
- •Soft contact lens wearer within one week prior to the study and during the study.
- •Rigid gas permeable, orthokeratology lens wear within 1 month prior to the study and during the study.
- •Current typical dietary intake of fish or oral supplements known to have anti-inflammatory properties;
- •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:
- •oOcular medication, category S3 and above;
- •oAny 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;
- •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;
- •Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
- •The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
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