A prospective, open-label, contralateral daily wear, cross over, randomised clinical trial assessing the effect of wearing a novel and five commercially available contact lenses for 1 week on corneal topography worn in experienced myopic contact lens wearers

CIBA VISION Corporation0 个研究点目标入组 28 人开始时间: 2010年8月5日最近更新: 2020年1月13日

研究概览

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•be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. If participant is a child or adolescent, a parent or legal guardian must be able to provide this consent,
•- be between the ages of 18 and 45 years old inclusive
•- be myopic (short sighted) -0.75D to -4.25D with astigmatism no more than -1.00 D
•- 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 6/12 (20/40) or better in each eye with contact lenses.
•- be experienced wearing contact lenses

•- Pre-existing ocular irritation that would preclude contact lens fitting;
•- Strabismus or amblyopia;
•- Any ocular condition that may preclude safe wearing of contact lenses (e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy);
•- Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal oedema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses;
•- Any systemic disease that may adversely affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
•- Eye surgery within 12 weeks immediately prior to enrolment for this trial;
•- Previous corneal refractive surgery;
•- Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
•- Contraindications to hydrogel contact lens wear;
•- Worn orthokeratology lenses within the past 3 months;
•- Currently enrolled in another clinical trial;
•- Pregnancy (verbal report from participant will suffice).

发起方