Comparison in the Efficiency and Safety Between the Applications of New Hypochlorous Acid Eyelid Wipes and Povidone Lodine on the Eye Surface
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- SPEED Questionnaire
研究概览
简要总结
The use of povidone iodine solution for prophylaxis of endophthalmitis is well established for intraocular procedures like cataract surgery and for injections of anti-VEGF agents for retinal diseases such as age-related macular degeneration. Unfortunately iodine is unfriendly to the ocular surface, and when repeated often enough (some patients require up to monthly injections of anti-VEGF agents for the entire year), corneal epitheliopathy and secondary dry eye results. Unfortunately, there is no good alternative to cleaning patient's eyelid at the moment. Ocudox is a relatively new antibacterial product (spraying on eyelid wipe) which contains Neutrox (pure hypochlorous acid) that kills many microbes, but remain very friendly and non-toxic for the ocular surface.
详细描述
In a multicentre study involving 71 eyes, reported at a conference abstract (ARVO), Avenova (similar ingredients as Ocudox) reduces bacteria on ocular skin surface by more than 90% without altering the diversity of bacteria on the ocular skin surface in any significant way. This lowering of the bacterial load was particularly noteworthy for all staphylococci, including S. epidermidis, the most frequently recovered species. At 20 minutes following treatment, 138 unique bacterial strains belonging to 26 different species were recovered.
However, the efficacy of anti-microbial action has not been compared to the gold standard of a single wipe with povidone iodine solution. Investigator intend to compare pre and post treatment of Ocudox and a single use of povidine iodine solution at Day 14 in terms of the alteration of the conjunctival microbiome of the eye and the effect on the ocular surface.
Clinical significance The study has implications on the prophylaxis of infection in many common ophthalmic procedures conducted in Singapore National Eye Centre and many places in the world.
- OBJECTIVES The aim of this study is to compare pre and post-treatment of the application of Ocudox to a single use of povidine iodine solution at Day 14in terms of the alteration of the conjunctival microbiome and the integrity of the eye.
- EXPECTED RIKS AND BENEFITS There would be no expected risk involved as all the evaluations are non-invasive. However, there will be some slight discomfort from measure tear volume or tear collection (Schirmer's strips) and also slight discomfort from culturing procedure.
There are no known benefits from participation in this study. However, this project may have the potential to prevent infection in many common ophthalmic procedures conducted in Singapore National Eye Centre and many places in the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Investigator will be masked
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 50 to 60 years old with Meibomian Gland Dysfunction (MGD)
- •Clear of exclusion criteria
- •Willing to perform all eye examinations in this study
排除标准
- •Participants diagnosed with diabetes
- •No recent eye surgery or eye procedure within 1 month
- •Participants who are unsuitable for Oculus K5M recording such as musculoskeletal problems
- •Participants who are unable to tolerate Oculus K5M recording machine
- •Is pregnant, lactating or planning a pregnancy
- •Any other specified reason as determined by clinical investigator
研究组 & 干预措施
Ocudox lid wiped
干预措施: Eyelid cleaning (Procedure)
Povidone Iodine
干预措施: Eyelid cleaning (Procedure)
结局指标
主要结局
SPEED Questionnaire
时间窗: 21 days
To compare the frequency and severity of dry eye symptoms at baseline and after 21 days
次要结局
未报告次要终点
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre