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Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

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CooperVision

Status

Completed

Conditions

Presbyopia

Treatments

Device: Omafilcon B lens (control)
Device: Comfilcon A lens (test)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03417557
CV-18-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Comfilcon A lens (test)
Experimental group
Description:
Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
Treatment:
Device: Comfilcon A lens (test)
Omafilcon B Lens (control)
Active Comparator group
Description:
Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.
Treatment:
Device: Omafilcon B lens (control)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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