Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02193178
Collaborator
(none)
15
2
1
21
7.5
0.4

Study Details

Study Description

Brief Summary

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: comfilcon A Toric
N/A

Detailed Description

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: comfilcon A toric

Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Device: comfilcon A Toric
Contact lenses
Other Names:
  • Biofinity
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Comfort [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.

    2. Overall Vision [2 weeks prior to baseline, Baseline, 2 weeks post]

      Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.

    3. Handling [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy

    4. Overall Satisfaction [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.

    5. Lens Fit - Rotation [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.

    6. Lens Fit - Overall Stability [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability

    7. Lens Fit Acceptance [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)

    8. Anterior Ocular Health - Palpebral Hyperemia and Roughness [Baseline and 2 weeks]

      Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe

    9. Anterior Ocular Health - Bulbar and Limbal Redness [Baseline and 2 weeks]

      Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection

    10. Anterior Ocular Health - Corneal Staining [Baseline and 2 weeks]

      Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area

    11. Anterior Ocular Health - Conjunctival Staining and Indentation [Baseline and 2 weeks]

      Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe

    12. Visual Acuity [2 weeks prior to baseline, Baseline, 2 weeks post baseline]

      Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.

    13. Subjective Preference - Comfort [Baseline and 2 weeks]

      Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

    14. Preference - Vision [Baseline and 2 weeks]

      Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

    15. Preference - Handling [Baseline and 2 weeks]

      Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

    16. Overall Preference [Baseline and 2 weeks]

      Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

    17. Investigator Acceptability [Baseline and 2 weeks]

      Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Has had an oculo-visual examination in the last two years

    • Is at least 18 years of age 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 correctable to a visual acuity of 20/50 or better (in at least one eye)

    • Currently wears soft toric contact lenses in both eyes

    • Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:

    • -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25

    • +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25

    • -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75

    • -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75

    • +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75

    • Has clear corneas and no active ocular disease

    • Demonstrates an acceptable fit with the study lenses

    Exclusion Criteria:
    • 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 abnormality that would affect the wearing of contact lenses;

    • Has undergone corneal refractive surgery;

    • Is participating in any other type of eye related clinical or research study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University Bloomington Indiana United States 47405
    2 Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston Houston Texas United States 77204

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Principal Investigator: Jan Bergmanson, OD PhD, Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
    • Principal Investigator: Pete Kollbaum, OD PhD, Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT02193178
    Other Study ID Numbers:
    • CV-14-05
    First Posted:
    Jul 17, 2014
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Overall Participants
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Period Title: Overall Study
    STARTED 15
    COMPLETED 13
    NOT COMPLETED 2

    Baseline Characteristics

    Arm/Group Title Overall Baseline Characteristics
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Overall Participants 14
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    14
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    29
    (11)
    Sex: Female, Male (Count of Participants)
    Female
    11
    78.6%
    Male
    3
    21.4%
    Region of Enrollment (participants) [Number]
    United States
    14
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Comfort
    Description Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13
    Mean (Standard Deviation) [units on a scale]
    80
    (16)
    91
    (9)
    88
    (11)
    2. Primary Outcome
    Title Overall Vision
    Description Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13
    Mean (Standard Deviation) [units on a scale]
    75
    (17)
    85
    (15)
    80
    (18)
    3. Primary Outcome
    Title Handling
    Description Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13
    Mean (Standard Deviation) [units on a scale]
    88
    (25)
    89
    (16)
    94
    (9)
    4. Primary Outcome
    Title Overall Satisfaction
    Description Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13
    Mean (Standard Deviation) [units on a scale]
    90
    (10)
    92
    (9)
    89
    (10)
    5. Primary Outcome
    Title Lens Fit - Rotation
    Description Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 12 14 13
    Measure eyes 24 28 26
    0 degrees
    18
    29
    21
    <=5 degrees
    64
    71
    64
    <=10 degrees
    93
    86
    89
    <=15 degrees
    93
    93
    93
    >15 degrees
    7
    7
    7
    6. Primary Outcome
    Title Lens Fit - Overall Stability
    Description Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.
    Arm/Group Title Habitual Lenses Baseline 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 12 14 13
    Measure eyes 24 28 26
    Mean (Standard Deviation) [units on a scale]
    2.8
    (0.7)
    3.3
    (0.8)
    3.3
    (0.6)
    7. Primary Outcome
    Title Lens Fit Acceptance
    Description General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 12 14 13
    Measure eyes 24 28 26
    Mean (Standard Deviation) [units on a scale]
    3.0
    (0.6)
    3.5
    (0.7)
    3.3
    (0.4)
    8. Primary Outcome
    Title Anterior Ocular Health - Palpebral Hyperemia and Roughness
    Description Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    Measure eyes 28 26
    Palpebral Conjunctival Hyperemia (Superior)
    0.75
    (0.81)
    0.48
    (0.33)
    Palpebral Conjunctival Hyperemia (Inferior)
    0.71
    (0.60)
    0.50
    (0.35)
    Palpebral Conjunctival Papillae (Superior)
    0.61
    (0.46)
    0.58
    (0.44)
    Palpebral Conjunctival Papillae (Inferior)
    0.64
    (0.43)
    0.54
    (0.37)
    9. Primary Outcome
    Title Anterior Ocular Health - Bulbar and Limbal Redness
    Description Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    Measure eyes 28 26
    Bulbar (nasal)
    1.00
    (0.71)
    0.67
    (0.45)
    Bulbar (temporal)
    1.00
    (0.75)
    0.67
    (0.45)
    Bulbar (superior)
    0.79
    (0.76)
    0.63
    (0.46)
    Bulbar (inferior)
    0.79
    (0.76)
    0.62
    (0.45)
    Limbal (nasal)
    0.71
    (1.07)
    0.21
    (0.38)
    Limbal (temporal)
    0.71
    (1.07)
    0.21
    (0.38)
    Limbal (superior)
    0.80
    (1.06)
    0.21
    (0.38)
    Limbal (inferior)
    0.73
    (1.09)
    0.19
    (0.35)
    10. Primary Outcome
    Title Anterior Ocular Health - Corneal Staining
    Description Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    Measure eyes 28 26
    Central
    0.00
    (0.00)
    0.00
    (0.00)
    Nasal
    0.11
    (0.31)
    0.04
    (0.20)
    Temporal
    0.00
    (0.00)
    0.00
    (0.00)
    Superior
    0.04
    (0.19)
    0.04
    (0.20)
    Inferior
    0.11
    (0.31)
    0.12
    (0.33)
    11. Primary Outcome
    Title Anterior Ocular Health - Conjunctival Staining and Indentation
    Description Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conjunctival Staining (Baseline) Conjunctival Indentation (Baseline) Conjunctival Staining (2 Weeks) Conjunctival Indentation (2 Weeks)
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13 13
    Measure eyes 28 28 26 26
    Nasal
    0.34
    (0.51)
    0.21
    (0.40)
    0.54
    (0.49)
    0.37
    (0.52)
    Temporal
    0.23
    (0.40)
    0.11
    (0.31)
    0.29
    (0.51)
    0.38
    (0.50)
    Superior
    0.07
    (0.18)
    0.00
    (0.00)
    0.15
    (0.31)
    0.02
    (0.10)
    Inferior
    0.18
    (0.43)
    0.13
    (0.35)
    0.19
    (0.38)
    0.21
    (0.38)
    12. Primary Outcome
    Title Visual Acuity
    Description Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
    Time Frame 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Outcome Measure Data

    Analysis Population Description
    One participant discontinued and therefore data was not included in analysis.
    Arm/Group Title Habitual Lenses Comfilcon A - Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 14 13
    High Contrast High Illumination (monocular)
    0.06
    (0.14)
    0.06
    (0.08)
    0.07
    (0.14)
    High Contrast High Illumination (binocular)
    -0.04
    (0.09)
    0.00
    (0.07)
    -0.03
    (0.09)
    High Contrast Low Illumination (monocular)
    0.19
    (0.13)
    0.20
    (0.09)
    0.23
    (0.13)
    High Contrast Low Illumination (binocular)
    0.10
    (0.09)
    0.15
    (0.10)
    0.17
    (0.14)
    13. Primary Outcome
    Title Subjective Preference - Comfort
    Description Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A- Baseline Comfilcon A-2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    comfilcon A lenses
    57
    69
    No preference
    43
    23
    Habitual lenses
    0
    8
    14. Primary Outcome
    Title Preference - Vision
    Description Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    comfilcon A XR lenses
    50.0
    46.2
    No preference
    28.6
    15.4
    Habitual lenses
    21.4
    38.5
    15. Primary Outcome
    Title Preference - Handling
    Description Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    Missing data for handling preference for one participant.
    Arm/Group Title Comfilcon A- Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    comfilcon A lenses
    21.4
    31
    No preference
    64.3
    54
    Habitual lenses
    7.1
    15
    Missing
    7.1
    0
    16. Primary Outcome
    Title Overall Preference
    Description Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A Baseline Comfilcon A - 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    comfilcon A lenses
    50
    46
    No preference
    43
    23
    Habitual lenses
    7
    31
    17. Primary Outcome
    Title Investigator Acceptability
    Description Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfilcon A Baseline Comfilcon A 2 Weeks
    Arm/Group Description Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
    Measure Participants 14 13
    Agree
    86
    85
    Neither Agree nor Disagree
    14
    15
    Disagree
    0
    0

    Adverse Events

    Time Frame From dispense up to two weeks for each study lenses
    Adverse Event Reporting Description
    Arm/Group Title Comfilcon A Toric XR MTO
    Arm/Group Description Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses. comfilcon A Toric XR (MTO) contact lenses
    All Cause Mortality
    Comfilcon A Toric XR MTO
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Comfilcon A Toric XR MTO
    Affected / at Risk (%) # Events
    Total 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Comfilcon A Toric XR MTO
    Affected / at Risk (%) # Events
    Total 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.

    Results Point of Contact

    Name/Title Sr. Manager, Clinical Research
    Organization CooperVision, Inc.
    Phone 9257306754
    Email pchamberlain@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT02193178
    Other Study ID Numbers:
    • CV-14-05
    First Posted:
    Jul 17, 2014
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020