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The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02510820
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
5
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Condition or Disease Intervention/Treatment Phase
  • Device: comfilcon A
  • Device: Synergi
  • Device: Biotrue
  • Other: stenfilcon A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Synergi / comfilcon A

Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.

Device: comfilcon A
soft contact lens
Other Names:
  • Biofinity

    • Device: Synergi
    Multipurpose solution

    Other: stenfilcon A
    daily disposable contact lenses for washout period
    Active Comparator: Biotrue / comfilcon A

    Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.

    Device: comfilcon A
    soft contact lens
    Other Names:
  • Biofinity

    • Device: Biotrue
    Multipurpose solution

    Other: stenfilcon A
    daily disposable contact lenses for washout period

    Outcome Measures

    Primary Outcome Measures

    1. Conjunctival Hyperaemia [Baseline, 1 week, 2 weeks, 4 weeks]

      Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    2. Limbal Hyperaemia [Baseline, 1 week, 2 weeks, 4 weeks]

      Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    3. Corneal Staining [Baseline, 1 week, 2 weeks, 4 weeks]

      Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.

    4. Papillary Conjunctivitis [Baseline, 1 week, 2 weeks, 4 weeks]

      Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    5. Comfort [1 week]

      Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    6. Comfort [2 weeks]

      Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    7. Comfort [4 weeks]

      Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    8. Vision [1 week]

      Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    9. Vision [2 weeks]

      Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    10. Vision [4 weeks]

      Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    11. Dryness [1 week, 2 weeks, 4 weeks]

      Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.

    12. Burning/Stinging [1 week, 2 weeks, 4 weeks]

      Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.

    13. Ocular Redness [1 week, 2 weeks, 4 weeks]

      Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.

    14. Ease of Lens Insertion [1 week, 2 weeks, 4 weeks]

      Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.

    15. Ease of Lens Removal [1 week, 2 weeks, 4 weeks]

      Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.

    16. Ease of Use of Solution [1 week, 2 weeks, 4 weeks]

      Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy

    17. Overall Score [1 week, 2 weeks, 4 weeks]

      Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. They are of legal age and capacity to volunteer.

    2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

    3. They are willing and able to follow the protocol.

    4. They agree not to participate in other clinical research for the duration of this study.

    5. They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)

    6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.

    7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

    8. They currently use silicone hydrogel soft contact lenses.

    9. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

    Exclusion Criteria:

    1. They have an ocular disorder which would normally contra-indicate contact lens wear.

    2. They have a systemic disorder which would normally contra-indicate contact lens wear.

    3. They are using any topical medication such as eye drops or ointment.

    4. They have had cataract surgery.

    5. They have had corneal refractive surgery.

    6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

    7. They are pregnant or lactating.

    8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

    9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

    10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eurolens Research Manchester United Kingdom M13 9PL

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Principal Investigator: Carole Maldonado-Codina, University of Manchester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT02510820
    Other Study ID Numbers:
    • EX-MKTG-54
    First Posted:
    Jul 29, 2015
    Last Update Posted:
    Feb 1, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Myopia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Three subjects were not dispensed the combination of multipurpose solutions.
    Arm/Group Title Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
    Arm/Group Description Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination. Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
    Period Title: First Intervention (4 Weeks)
    STARTED 21 27
    COMPLETED 21 26
    NOT COMPLETED 0 1
    Period Title: First Intervention (4 Weeks)
    STARTED 21 26
    COMPLETED 21 26
    NOT COMPLETED 0 0
    Period Title: First Intervention (4 Weeks)
    STARTED 21 26
    COMPLETED 20 26
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Overall Baseline Characteristics
    Arm/Group Description Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
    Overall Participants 51
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.3
    (10.9)
    Sex: Female, Male (Count of Participants)
    Female
    34
    66.7%
    Male
    17
    33.3%
    Region of Enrollment (participants) [Number]
    United Kingdom
    51
    100%

    Outcome Measures

    1. Primary Outcome
    Title Conjunctival Hyperaemia
    Description Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
    Time Frame Baseline, 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    Baseline
    0.84
    (0.24)
    0.87
    (0.21)
    1 week
    0.87
    (0.21)
    0.87
    (0.22)
    2 weeks
    0.88
    (0.24)
    0.83
    (0.21)
    4 weeks
    0.90
    (0.21)
    0.82
    (0.17)
    2. Primary Outcome
    Title Limbal Hyperaemia
    Description Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
    Time Frame Baseline, 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    Baseline
    0.73
    (0.26)
    0.77
    (0.22)
    1 week
    0.80
    (0.23)
    0.75
    (0.24)
    2 weeks
    0.73
    (0.25)
    0.70
    (0.26)
    4 weeks
    0.78
    (0.22)
    0.72
    (0.21)
    3. Primary Outcome
    Title Corneal Staining
    Description Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
    Time Frame Baseline, 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    Baseline
    0.30
    (0.48)
    0.17
    (0.34)
    1 week
    0.34
    (0.40)
    0.67
    (0.47)
    2 weeks
    0.38
    (0.46)
    0.59
    (0.54)
    4 weeks
    0.31
    (0.42)
    0.62
    (0.51)
    4. Primary Outcome
    Title Papillary Conjunctivitis
    Description Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
    Time Frame Baseline, 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    Baseline
    1.04
    (0.22)
    1.07
    (0.24)
    1 week
    1.05
    (0.24)
    1.04
    (0.23)
    2 weeks
    1.05
    (0.26)
    1.06
    (0.20)
    4 weeks
    1.09
    (0.24)
    1.06
    (0.24)
    5. Primary Outcome
    Title Comfort
    Description Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    Comfort after insertion
    88.7
    (11.4)
    83.4
    (17.9)
    Comfort before removal
    76.8
    (17.2)
    72.4
    (22.4)
    Overall comfort
    85.6
    (11.8)
    82.8
    (13.9)
    6. Primary Outcome
    Title Comfort
    Description Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 45
    Comfort after insertion
    87.0
    (12.6)
    85.6
    (14.8)
    Comfort before removal
    78.1
    (19.4)
    73.9
    (20.9)
    Overall comfort
    84.7
    (14.9)
    83.2
    (14.8)
    7. Primary Outcome
    Title Comfort
    Description Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 45 45
    Comfort after insertion
    88.3
    (11.0)
    87.3
    (15.5)
    Comfort before removal
    76.1
    (21.2)
    75.0
    (20.0)
    Overall comfort
    85.3
    (14.3)
    84.5
    (14.0)
    8. Primary Outcome
    Title Vision
    Description Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    Distance vision
    91.1
    (12.7)
    92.1
    (10.4)
    Variable vision
    92.1
    (12.7)
    92.1
    (12.4)
    Night vision
    90.4
    (12.3)
    91.6
    (11.2)
    9. Primary Outcome
    Title Vision
    Description Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 45
    Distance vision
    92.8
    (8.7)
    91.1
    (13.0)
    Variable vision
    94.3
    (9.6)
    90.5
    (12.3)
    Night vision
    93.2
    (8.1)
    90.8
    (12.7)
    10. Primary Outcome
    Title Vision
    Description Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 45 45
    Distance vision
    92.5
    (8.8)
    92.6
    (10.4)
    Variable vision
    92.6
    (12.5)
    94.1
    (9.5)
    Night vision
    92.1
    (8.6)
    91.9
    (11.5)
    11. Primary Outcome
    Title Dryness
    Description Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    1 week
    82.8
    (16.3)
    79.3
    (20.0)
    2 weeks
    79.5
    (20.5)
    80.2
    (19.8)
    4 weeks
    79.9
    (20.9)
    81.7
    (20.3)
    12. Primary Outcome
    Title Burning/Stinging
    Description Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    1 week
    94.3
    (13.0)
    95.7
    (9.4)
    2 weeks
    96.0
    (8.4)
    96.8
    (8.7)
    4 weeks
    94.6
    (10.9)
    96.5
    (9.3)
    13. Primary Outcome
    Title Ocular Redness
    Description Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    1 week
    96.0
    (9.9)
    96.8
    (6.4)
    2 weeks
    95.4
    (9.6)
    96.5
    (8.2)
    4 weeks
    95.5
    (8.1)
    95.7
    (9.9)
    14. Primary Outcome
    Title Ease of Lens Insertion
    Description Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    1 week
    90.9
    (11.8)
    93.2
    (8.5)
    2 weeks
    90.8
    (8.8)
    93.4
    (8.9)
    4 weeks
    91.8
    (8.7)
    93.5
    (8.8)
    15. Primary Outcome
    Title Ease of Lens Removal
    Description Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    1 week
    91.1
    (14.0)
    92.2
    (11.8)
    2 weeks
    90.7
    (11.9)
    94.0
    (10.5)
    4 weeks
    91.3
    (11.2)
    94.4
    (8.2)
    16. Primary Outcome
    Title Ease of Use of Solution
    Description Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 47 48
    1 week
    87.7
    (17.3)
    92.2
    (11.4)
    2 weeks
    88.2
    (17.5)
    93.6
    (11.0)
    4 weeks
    88.7
    (15.3)
    92.7
    (12.6)
    17. Primary Outcome
    Title Overall Score
    Description Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.
    Time Frame 1 week, 2 weeks, 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).
    Arm/Group Title Synergi / Comfilcon A Biotrue / Comfilcon A
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution
    Measure Participants 46 47
    1 week
    90.3
    (12.6)
    90.6
    (11.7)
    2 weeks
    88.3
    (15.0)
    90.7
    (12.5)
    4 weeks
    88.8
    (15.4)
    91.7
    (12.7)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
    Arm/Group Description Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Synergi: Multipurpose solution Biotrue: Multipurpose solution Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. comfilcon A: soft contact lens Biotrue: Multipurpose solution Synergi: Multipurpose solution
    All Cause Mortality
    Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/27 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Sr. Manager Global Medical Scientific Affairs
    Organization CooperVision
    Phone (925) 621-3761
    Email javega@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT02510820
    Other Study ID Numbers:
    • EX-MKTG-54
    First Posted:
    Jul 29, 2015
    Last Update Posted:
    Feb 1, 2017
    Last Verified:
    Jan 1, 2017