Prospective, single-group, open label, bilateral daily wear study to investigate bacterial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses in healthy volunteers

Institute for Eye Research0 个研究点目标入组 40 人开始时间: 2009年4月3日最近更新: 2020年1月13日

试验速览

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•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
•Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses
•Be experienced or may be inexperienced at wearing contact lenses

•Pre-existing ocular irritation, injury or condition that would preclude contact lens fitting and safe wearing of contact lenses;
•Any systemic disease that adversely affects ocular health;
•any active ocular disease that would affect wearing of contact lenses;
•A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
•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 manner or beneficial manner;
•Eye surgery within 12 weeks immediately prior to enrolment for this trial;
•Previous corneal refractive surgery;
•Contraindications to contact lens wear;
•Currently enrolled in another clinical trial;
•Participation in a clinical trial within the previous 2 weeks for dispensing studies;
•Allergy or intolerance to silver;
•Pregnant women are excluded from the trial - formal testing of pregnancy is not required. A participant's verbal report is sufficient.

发起方

Institute for Eye Research