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Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
comfilcon A
samfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Golden Optometric Group
  • Complete Eye Care of Medina
  • Brock & Houlford
  • Tempany's Boutique Opticians
  • David Gould Opticians

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

comfilcon A

samfilcon A

Arm Description

Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.

Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Wearing Times
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
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
Vision Quality
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
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.
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
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
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.
White Spot Deposits
Number of white spot deposits for comfilcon A and samfilcon A lenses.
Visual Acuity (VA)
Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
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)
Corneal Coverage
Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete
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
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
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
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
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

Full Information

First Posted
August 31, 2015
Last Updated
September 21, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02542072
Brief Title
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Official Title
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
Arm Title
samfilcon A
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
samfilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
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).
Time Frame
Baseline, 2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Comfortable Wearing Time Via SMS (Short Message Service)
Description
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).
Time Frame
Days 3, 12, 26
Title
Wearing Times
Description
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Deterioration in Comfort
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Vision Quality
Description
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Overall Lens Handling
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Biomicroscopy Scores
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Lens Surface Wetting
Description
Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Film Deposits
Description
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.
Time Frame
2 weeks and 4 weeks
Title
White Spot Deposits
Description
Number of white spot deposits for comfilcon A and samfilcon A lenses.
Time Frame
2 weeks and 4 weeks
Title
Visual Acuity (VA)
Description
Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Lens Centration
Description
Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Corneal Coverage
Description
Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete
Time Frame
Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Title
Post-Blink Movement
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Primary Gaze Lag
Description
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
Time Frame
Baseline, 2 weeks, and 4 weeks
Title
Lens Tightness Push-up
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Overall Fit Acceptance
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Dryness
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Young
Organizational Affiliation
VisionCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Brock & Houlford
City
Chew Magna
State/Province
Bristol
ZIP/Postal Code
BS40 8PR
Country
United Kingdom
Facility Name
Tempany's Boutique Opticians
City
Broadstone
State/Province
Dorset
ZIP/Postal Code
BH18 8DP
Country
United Kingdom
Facility Name
David Gould Opticians
City
Rawtenstall
State/Province
Lancashire
ZIP/Postal Code
BB4 7QN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

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