Clinical trial NCT03417557: Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Official title: Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Detailed description: This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Eligibility criteria: Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
* Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
* Is able to participate in Parts A and B related to this work.
* Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
* Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
* Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Visual Acuity
timeFrame: up to 3 hours
Secondary outcomes:
measure: Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
timeFrame: up to 3 hours
measure: Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
timeFrame: up to 3 hours
measure: Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
References: