WithdrawnPhase 4ACTRN12618001897257

NaturalVue Multifocal Benchmarking Trial

Prospective, double-masked, randomized, crossover, bilateral wear dispensing trial to assess visual performance of NaturalVue Multifocal lenses against EDOF lenses

Sponsor

Brien Holden Vision Institute

Enrollment

45 participants

Start Date

Feb 4, 2019

Study Type

Interventional

Conditions

Presbyopia

Summary

This study aims to compare the visual performance of NaturalVue Multifocal contact lenses with prototype multifocal contact lenses. Participants will wear each lens type in both eyes for a minimum of 7 days. After this period, vision and subjective ratings with each lens type will be assessed.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Inclusion Criteria6

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be presbyopic and at least 40 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.
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be suitable and willing to wear contact lenses.

Exclusion Criteria8

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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
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.

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Interventions

Each participant will wear NaturalVue Multifocal lenses and prototype EDOF lenses bilaterally for minimum 7 days (minimum 8 hours per day) with a minimum 2-night wash-out period between lens types. B

Each participant will wear NaturalVue Multifocal lenses and prototype EDOF lenses bilaterally for minimum 7 days (minimum 8 hours per day) with a minimum 2-night wash-out period between lens types. Both lens types are multifocal lenses which assist with correcting a range of vision from distance to near. In the middle of the wear period, participants will complete a questionnaire while wearing the lenses. Also at the assessment visit at the end of the wear period, participants will be asked how many days they wore the lenses and average number of hours per day of wearing the lenses.