Assessment of a Novel Multifocal Contact Lens Trial Fitting Experience

CooperVision International Limited (CVIL)2 个研究点分布在 1 个国家目标入组 25 人开始时间: 2026年5月31日最近更新: 2026年5月22日

适应症

试验速览

This study will assess a trial fitting experience with contact lenses.

This study is designed to evaluate a contact lens fitting experience utilizing an at home trial kit.

•They are at least 40 years of age.
•They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
•They habitually wear MyDay sphere or MyDay Energys contact lenses (including sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction).
•They have a minimum reading add of +0.75DS (based on their manifest refraction) and no more than +2.50DS.
•They have spherical equivalent refractive error between +4.50 to -11.00DS (some restrictions apply based on near add availability)
•They have refractive astigmatism of no greater than 0.75DC in each eye.
•They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye with manifest refraction.
•They report at least one near-vision difficult symptom consistent with presbyopia as evidenced by a response of 'slight difficult' or worse on ³ 1 item of the Near Activity Visual Questionnaire (NAVQ-P) at screening.

•Is participating in any concurrent clinical or research trial.
•They have an ocular disorder which would normally contraindicate contact lens wear.
•They have a systemic disorder which would normally contraindicate contact lens wear.
•They are pseudophakic or aphakic.
•They have had corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
•Self-reports as pregnant, lactating or planning a pregnancy at the time of enrollment.

发起方

CooperVision International Limited (CVIL)

申办方类型

Industry

责任方

Sponsor

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