ACTRN12611000586910已完成未知
A prospective, doubled-masked, cross-over, randomised clinical trial to compare solution induced corneal staining rates between an investigational contact lens care solution, COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark] solutions with commercially available contact lenses worn contralaterally over two and eight hours in experienced contact lens wearers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 55
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;
- •-Be at least 18 years old, male or female;
- •-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;
- •-Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •-Be an experienced contact lens wearer;
- •-Be able to insert and remove contact lenses;
- •-Be willing to not wear contact lens wear for at least 24 hours before each stage of the clinical trial (after informed consent).
排除标准
- •-Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
- •-Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- •-Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the study;
- •-Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the study;
- •N.B.: Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial and at least 24 hours before study product is used;
- •-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •-Previous corneal refractive surgery;
- •-Contraindications to contact lens wear;
- •-Known allergy or intolerance to ingredients in any of the study products;
- •-Currently enrolled in another clinical trial.
- •-Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours -between in-house studies;
- •-Pregnancy*;
- •-The Investigator may, at his/her discretion, exclude anyone 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.
- •*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
研究者
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