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Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417557
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : February 10, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Comfilcon A lens (test) Device: Omafilcon B lens (control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Actual Study Start Date : January 12, 2018
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Comfilcon A lens (test)
Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
Device: Comfilcon A lens (test)
contact lens
Other Name: Biofinity multifocal toric Lens (test)

Active Comparator: Omafilcon B Lens (control)
Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.
Device: Omafilcon B lens (control)
contact lens
Other Name: Proclear multifocal toric lens (control)




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: up to 3 hours ]
    Visual acuity is assessed for test and control lens on a logMAR chart


Secondary Outcome Measures :
  1. Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity [ Time Frame: up to 3 hours ]
    Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

  2. Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity [ Time Frame: up to 3 hours ]
    Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

  3. Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity [ Time Frame: up to 3 hours ]
    Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417557


Locations
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United States, Indiana
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Coopervision, Inc.
  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03417557    
Other Study ID Numbers: CV-18-10
First Posted: January 31, 2018    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases