Prospective, participant-masked, bilateral wear, multiple arm, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in participants with presbyopia and/or myopia

Brien Holden Vision Pty Ltd0 个研究点目标入组 40 人开始时间: 2014年1月6日最近更新: 2020年1月13日

适应症

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 ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses.
•Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
•Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent).
•Have at least +1.00D of Add prescription for presbyopes
•Have at least -0.50D of myopic prescription for myopes

•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, Sjogrens 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 clinical 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 or beneficial manner at enrolment and/or during the clinical trial.
•NB: Systemic antihistamines are allowed on an as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial 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 clinical trial products.

发起方

Brien Holden Vision Pty Ltd