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Clinical Trials/NCT03417557
NCT03417557CompletedNot Applicable

Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses

Coopervision, Inc.2 sites in 1 country20 target enrollmentStarted: January 12, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Visual Acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: up to 3 hours

Visual acuity is assessed for test and control lens on a logMAR chart

Secondary Outcomes

  • Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity(up to 3 hours)
  • Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity(up to 3 hours)
  • Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity(up to 3 hours)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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