Prospective, controlled, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers

Brien Holden Vision Institute0 个研究点目标入组 200 人开始时间: 2012年10月16日最近更新: 2020年1月13日

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•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.
•-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 that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles.
•-Be experienced or inexperienced at wearing contact lenses.

•-Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
•-An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
•-Use of or a need for any therapeutic ocular medication up to 4 weeks prior to and during the trial;
•-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 manner or risk providing a false positive.
•-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 clinical trial products.
•-Currently enrolled in another clinical trial.

发起方

Brien Holden Vision Institute