Performance Comparison Between Comfilcon A and Senofilcon C Lenses

December 11, 2017 updated by: CooperVision, Inc.
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Whittier, California, United States, 90606
        • Golden Optometric Group
    • Florida
      • Ocoee, Florida, United States, 34761
        • Coan Eye Care & Optical Boutique
    • Minnesota
      • Edina, Minnesota, United States, 55436
        • Cornea & Contact Lens Institute of Minnesota
    • New York
      • Vestal, New York, United States, 13850
        • Sacco Eye Group
    • Ohio
      • New Albany, Ohio, United States, 43054
        • Vision Professionals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 34 years of age (inclusive)
  • Has had a self-reported eye exam in the last two years
  • Is a spherical soft contact lens wearer
  • Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
  • Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Has a contact lens prescription that fits within the available parameters of the study lenses.
  • Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

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

  • Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
  • Presents with clinically significant anterior segment abnormalities
  • Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.

  • Presents with slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Significant pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (or history in past year)
    • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
  • Is habitually using rewetting/ lubricating eye drops more than once per day
  • Is currently wearing daily disposable lenses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: comfilcon A
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
Device: comfilcon A
contact lens
Active Comparator: senofilcon C
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
Device: senofilcon C
contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Lens Fit Acceptance
Time Frame: Up to 1 month
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Up to 1 month
Corneal Coverage
Time Frame: Up to 1 month
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Up to 1 month
Lens Centration
Time Frame: Up to 1 month
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Up to 1 month
Post-blink Movement
Time Frame: Up to 1 month
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Up to 1 month
Lens Lag at Primary Gaze
Time Frame: Up to 1 month
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Up to 1 month
Tightness on Push up
Time Frame: Up to 1 month
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Up to 1 month
Lens Wettability
Time Frame: Up to 1 month
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Up to 1 month
Deposit Grading
Time Frame: Up to 1 month
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CooperVision, Inc.

Investigators

  • Study Director: Lyndon Jones, PhD, FAAO, FIACLE, FBCLA, Centre for Contact Lens Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 23, 2016

Study Completion (Actual)

November 23, 2016

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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