Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: comfilcon A; Device: samfilcon A

Detailed Description

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol
    • Chew Magna, Bristol, United Kingdom, BS40 8PR
      • Brock & Houlford
  • Dorset
    • Broadstone, Dorset, United Kingdom, BH18 8DP
      • Tempany's Boutique Opticians
  • Lancashire
    • Rawtenstall, Lancashire, United Kingdom, BB4 7QN
      • David Gould Opticians
• United States
  • California
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

• Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
• Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
• Spectacle cylinder 0.75D in both eyes.
• Correctable to 6/9 (20/30) in both eyes
• Be between 18 and 50 years of age (inclusive)
• Able to read, comprehend and sign an informed consent
• Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
• Willing to comply with the wear and study visit schedule

Exclusion:

• Existing Biofinity or Ultra wearers
• Any active corneal infection, injury or inflammation
• Systemic or ocular allergies, which might interfere with Contact Lens wear
• Systemic disease, which might interfere with Contact Lens wear
• Ocular disease, which might interfere with Contact Lens wear
• Strabismus or amblyopia
• Subjects who have undergone corneal refractive surgery
• Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
• Pregnant or lactating
• Use of systemic/topical medication contraindicating Contact Lens wear
• Diabetic
• Site employees or family members of site employees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: comfilcon A; Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.	Device: comfilcon A; contact lens
Active Comparator: samfilcon A; Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.	Device: samfilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).	Baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfortable Wearing Time Via SMS (Short Message Service)	Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).	Days 3, 12, 26
Wearing Times	Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.	Baseline, 2 weeks, 4 weeks
Deterioration in Comfort	Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent	Baseline, 2 weeks, 4 weeks
Vision Quality	Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.	Baseline, 2 weeks, 4 weeks
Overall Lens Handling	Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.	Baseline, 2 weeks, 4 weeks
Biomicroscopy Scores	Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe	Baseline, 2 weeks, 4 weeks
Lens Surface Wetting	Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent	Baseline, 2 weeks, 4 weeks
Film Deposits	Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.	2 weeks and 4 weeks
White Spot Deposits	Number of white spot deposits for comfilcon A and samfilcon A lenses.	2 weeks and 4 weeks
Visual Acuity (VA)	Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.	Baseline, 2 weeks, 4 weeks
Lens Centration	Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)	Baseline, 2 weeks, 4 weeks
Corneal Coverage	Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete	Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Post-Blink Movement	Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement	Baseline, 2 weeks, 4 weeks
Primary Gaze Lag	Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement	Baseline, 2 weeks, and 4 weeks
Lens Tightness Push-up	Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses. Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support	Baseline, 2 weeks, 4 weeks
Overall Fit Acceptance	Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect	Baseline, 2 weeks, 4 weeks
Dryness	Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry	Baseline, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Graeme Young, VisionCare

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-59 (VISA-406)