Prospective, single group clinical trial where a minimum of 100 participants will wear their own spectacles for a total of three months, investigating ocular surface characteristics and subjective responses such as comfort

Brien Holden Vision Institute0 个研究点目标入组 100 人开始时间: 2012年2月3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 participating.
•Have a current pair of pre-prescribed spectacles
•Is correctable to at least 6/12 (20/40) or better in each eye with spectacles.
•Have not worn contact lenses within the previous twelve months (They may have worn lenses not totalling more than two weeks in the past twelve months)

•Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids.
•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.
•Eye surgery within 12 weeks immediately prior to enrolment for this trial.
•Previous corneal refractive surgery..
•Currently enrolled in another clinical trial.
•Participation in a clinical trial within the previous 2 weeks

发起方

Brien Holden Vision Institute