ACTRN12608000626369已完成2 期
A pilot, prospective, open label, randomised, controlled, parallel design, three-month clinical trial to assess the safety of twice daily instillation of antibiotic versus saline drops during bilateral continuous wear of marketed contact lenses in experienced wearers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Be at least 18 years old;
- •Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- •Have ocular health findings considered to be normal and which would not prevent the participant from safely wearing contact lenses;
- •Have vision correctable to at least Snellen Visual Acuity of 6/12 (metres) or better in each eye with contact lenses, which means the participant can read within 3 lines of the nominal performance for human distance visiion (i.e. 6/6).
- •Be experienced at wearing contact lenses
排除标准
- •Pre-existing ocular irritation that would preclude contact lens fitting;
- •Had eye surgery or any systemic or ocular medication within 12 weeks immediately prior to enrolment for this trial;
- •Undergone corneal refractive surgery;
- •Worn RGP’s or orthokeratology lenses within the previous two weeks;
- •Contraindications to hydrogel contact lens wear;
- •Contraindication / allergy to tobramycin;
- •Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous two weeks.
- •Females are excluded from the trial
研究者
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