Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants Without Contamination of Contact Lenses
研究概览
简要总结
This study is a randomized, contralateral, investigator-masked non-dispensing study, to investigate the microbial contamination rates on the back surface of two types of soft contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister packs versus conventional lens packaging after short-term placement on the eye, and to compare the microbial contamination rates of the worn contact lenses to those on the participants' hands/fingers used to conduct lens insertion.
详细描述
This will be a prospective, single centre, randomized, contralateral, investigator-masked non-dispensing study. This study requires three visits of approx. 1 hour duration each.
At the first visit, the order in which the hydrogel (no EDTA) and silicone hydrogel (with EDTA) contact lenses are allocated to the study participants will be randomized. At the second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA or silicone hydrogel with EDTA).
At the third visit, participants will be randomly allocated to wear the hydrogel lens (with EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from Smart Touch Technology packaging.
At each visit, participants will be instructed to:
- Wash their hands prior to handling the contact lenses;
- Swab their thumb and two index fingers of the hand routinely used to conduct contact lens insertion using a sterile cotton swab moistened with sterile preservative free saline for the evaluation of skin microbiota;
- Follow the manufacturer's guidelines for lens insertion;
- Open the blister pack and insert the contact lens randomly assigned for the right eye;
- Open the blister pack and insert the contact lens assigned for the left eye;
- Contact lenses will be removed aseptically by a masked investigator after 45 minutes of lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and comprehend English and give informed consent as demonstrated by signing a Participant Information Statement and Consent Form;
- •Be at least 18 years old;
- •Experienced soft contact lens wearer;
- •Willing to refrain from wearing contact lenses for 24 hours prior to the scheduled study visit
排除标准
- •Under 18 years old;
- •Have any active corneal infection, ocular disease or systemic disease that would affect wearing of contact lenses;
- •Use or have a need for any systemic or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology either in an adverse manner or risk providing a false positive;
- •Have had eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •Have contraindications to contact lens wear;
- •Have a greater than 2 line reduction in habitual visual acuity while wearing the study contact lenses;
- •Be currently enrolled in another clinical trial;
- •Be pregnant (verbal self-report)
结局指标
主要结局
Number of Participants Without Contamination of Contact Lenses
时间窗: After 45 minutes of lens wear
Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear
次要结局
- Bacterial Counts of Worn Contact Lenses(After 45 minutes of lens wear)
研究者
Jacqueline Tan-Showyin
Senior Research Fellow
The University of New South Wales