A prospective, contralateral lens wear, randomised, controlled, 3-months clinical trial to test the efficacy and safety of a surface modified contact lens during continuous wear modality.

niversity of New South Wales0 个研究点目标入组 175 人开始时间: 2015年7月15日最近更新: 2020年1月13日

试验速览

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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.
•*Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
•*Have vision that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles.
•*Require contact lens correction in each eye between -0.75 and -6.00 D inclusive.

•*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’s 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 at enrolment (that would be required to be discontinued 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 manner or risk providing a false positive.
•*Eye surgery within 12 weeks immediately prior to enrolment for this trial.
•*Previous corneal refractive surgery.
•*Known allergy or intolerance to ingredients in any of the study products.
•*Currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks.
•*Pregnancy or lactating (Testing of pregnancy is not required. A participant’s verbal report is sufficient).

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