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Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03418064
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
3.1
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Condition or Disease Intervention/Treatment Phase
  • Device: Fanfilcon A toric lens
  • Device: Lotrafilcon B toric lens
 N/A

Detailed Description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
Actual Study Start Date :
Feb 10, 2018
Actual Primary Completion Date :
May 16, 2018
Actual Study Completion Date :
May 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: fanfilcon A toric

Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.

Device: Fanfilcon A toric lens
Contact lens
Other Names:
  • Avaira Vitality toric lens

    		•
    Active Comparator: lotrafilcon B

    Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.

    Device: Lotrafilcon B toric lens
    Contact lens
    Other Names:
  • AIR OPTIX for Astigmatism

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lens Centration [Baseline]

      Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

    2. Lens Centration [Dispense]

      Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

    3. Lens Centration [1 Month]

      Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

    4. Corneal Coverage [Baseline]

      Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

    5. Corneal Coverage [Dispense]

      Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

    6. Corneal Coverage [1 Month]

      Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

    7. Post-blink Movement [Baseline]

      Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

    8. Post-blink Movement [Dispense]

      Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

    9. Post-blink Movement [1 Month]

      Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

    10. Overall Fit Acceptance [Dispense]

      Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

    11. Overall Fit Acceptance [1 Month]

      Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

    Secondary Outcome Measures

    1. Average Hours of Wear Per Day [Baseline]

      Number of hours lenses are worn per day

    2. Average Hours of Wear Per Day [1 month]

      Number of hours lenses are worn per day

    3. Average Comfortable Wearing Time [Baseline]

      Typical time of day when subject first experiences lens awareness or irritation.

    4. Average Comfortable Wearing Time [1 Month]

      Typical time of day when subject first experiences lens awareness or irritation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Is between 18 and 40 years of age (inclusive)

    • Has had a self-reported visual exam in the last two years

    • Is an adapted soft contact lens wearer

    • Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)

    • Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.

    • 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.

    • Patient contact lens refraction should fit within the available parameters of the study lenses.

    • Is willing to comply with the wear schedule (at least 5 days per week, > 8 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 CL prescription outside the range of the available parameters of the study lenses.

    • Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.

    • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

    • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

    • Presence of clinically significant (grade 2-4) anterior segment abnormalities

    • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

    • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings

    • 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 (past or present)

    • Seborrheic eczema, 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Optometry Clinic, National Autonomous University Mexico City Mexico

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03418064
    Other Study ID Numbers:
    • EX-MKTG-90
    First Posted:
    Feb 1, 2018
    Last Update Posted:
    Nov 13, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Astigmatism

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Fanfilcon A Toric, Then Lotrafilcon B Toric Lotrafilcon B Toric, Then Fanfilcon A Toric
    Arm/Group Description Subjects wore fanfilcon A toric contact lens for 1 month, then lotrafilcon B toric contact lens. Fanfilcon A toric: contact lens Lotrafilcon B toric: contact lens Subjects wore lotrafilcon B toric contact lens for 1 month, then fanfilcon A toric contact lens. Lotrafilcon B toric: Contact lens Fanfilcon A toric: contact lens
    Period Title: First Intervention (1 Month)
    STARTED 21 21
    COMPLETED 21 21
    NOT COMPLETED 0 0
    Period Title: First Intervention (1 Month)
    STARTED 21 21
    COMPLETED 21 21
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens
    Arm/Group Description Each subject is randomized to wear either the fanfilcon A toric or lotrafilcon B toric contact lens as a matched pair and crossed over to second matched pair.
    Overall Participants 42
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    42
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    27.7
    (7.0)
    Sex: Female, Male (Count of Participants)
    Female
    35
    83.3%
    Male
    7
    16.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    0
    0%
    More than one race
    0
    0%
    Unknown or Not Reported
    42
    100%
    Region of Enrollment (participants) [Number]
    Mexico
    42
    100%

    Outcome Measures

    1. Primary Outcome
    Title Lens Centration
    Description Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Habitual Toric Lens at Baseline
    Arm/Group Description Subjects were evaluated at baseline with their habitual toric lenses.
    Measure Participants 42
    1-Optimal Centration
    41
    97.6%
    2-Decentration acceptable
    1
    2.4%
    3-Decentranation Unacceptable
    0
    0%
    2. Primary Outcome
    Title Lens Centration
    Description Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
    Time Frame Dispense

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric at Dispense Lotrafilcon B Toric at Dispense
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    1-Optimal Centration
    42
    100%
    42
    NaN
    2-Decentration acceptable
    0
    0%
    0
    NaN
    3-Decentranation Unacceptable
    0
    0%
    0
    NaN
    3. Primary Outcome
    Title Lens Centration
    Description Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Lens at 1 Month Lotrafilcon B Toric at 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    1-Optimal Centration
    42
    100%
    42
    NaN
    2-Decentration acceptable
    0
    0%
    0
    NaN
    3-Decentranation Unacceptable
    0
    0%
    0
    NaN
    4. Primary Outcome
    Title Corneal Coverage
    Description Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Habitual Toric Lens at Baseline
    Arm/Group Description Subjects were evaluated at baseline with their habitual toric lenses.
    Measure Participants 42
    Full Coverage (Yes)
    42
    100%
    Incomplete (No)
    0
    0%
    5. Primary Outcome
    Title Corneal Coverage
    Description Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
    Time Frame Dispense

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric at Dispense Lotrafilcon B Toric at Dispense
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Full Coverage (Yes)
    42
    100%
    42
    NaN
    Incomplete (No)
    0
    0%
    0
    NaN
    6. Primary Outcome
    Title Corneal Coverage
    Description Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Lens at 1 Month Lotrafilcon B Toric at 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Full Coverage (Yes)
    42
    100%
    42
    NaN
    Incomplete (No)
    0
    0%
    0
    NaN
    7. Primary Outcome
    Title Post-blink Movement
    Description Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Habitual Toric Lens at Baseline
    Arm/Group Description Subjects were evaluated at baseline with their habitual toric lenses.
    Measure Participants 42
    Mean (Standard Deviation) [score on a scale]
    2.17
    (0.5)
    8. Primary Outcome
    Title Post-blink Movement
    Description Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
    Time Frame Dispense

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric at Dispense Lotrafilcon B Toric at Dispense
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [score on a scale]
    2.02
    (0.2)
    2.05
    (0.5)
    9. Primary Outcome
    Title Post-blink Movement
    Description Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Lens at 1 Month Lotrafilcon B Toric at 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [score on a scale]
    2.00
    (0.0)
    2.10
    (0.4)
    10. Primary Outcome
    Title Overall Fit Acceptance
    Description Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
    Time Frame Dispense

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Contact Lens Dispense Lotrafilcon B Toric Contact Lens Dispense
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [units on a scale]
    3.8
    (0.5)
    2.4
    (1.0)
    11. Primary Outcome
    Title Overall Fit Acceptance
    Description Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Contact Lens 1 Month Lotrafilcon B Toric Contact Lens 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [units on a scale]
    3.9
    (0.4)
    2.5
    (0.9)
    12. Secondary Outcome
    Title Average Hours of Wear Per Day
    Description Number of hours lenses are worn per day
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Habitual Toric Lens
    Arm/Group Description Subjects were evaluated at baseline with their habitual toric lenses.
    Measure Participants 42
    Mean (Standard Deviation) [hours per day]
    13.8
    (3.0)
    13. Secondary Outcome
    Title Average Hours of Wear Per Day
    Description Number of hours lenses are worn per day
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Lens at 1 Month Lotrafilcon B Toric at 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [hours per day]
    14.1
    (2.9)
    14.0
    (2.6)
    14. Secondary Outcome
    Title Average Comfortable Wearing Time
    Description Typical time of day when subject first experiences lens awareness or irritation.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Habitual Toric Lens
    Arm/Group Description Subjects were evaluated at baseline with their habitual toric lenses.
    Measure Participants 42
    Mean (Standard Deviation) [hours per day]
    11.5
    (2.9)
    15. Secondary Outcome
    Title Average Comfortable Wearing Time
    Description Typical time of day when subject first experiences lens awareness or irritation
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fanfilcon A Toric Lens at 1 Month Lotrafilcon B Toric at 1 Month
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    Measure Participants 42 42
    Mean (Standard Deviation) [hours per day]
    11.4
    (3.3)
    11.0
    (3.4)

    Adverse Events

    Time Frame From dispense to completion of follow up, up to 1 month.
    Adverse Event Reporting Description
    Arm/Group Title Fanfilcon A Toric Lotrafilcon B Toric
    Arm/Group Description Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
    All Cause Mortality
    Fanfilcon A Toric Lotrafilcon B Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/42 (0%)
    Serious Adverse Events
    Fanfilcon A Toric Lotrafilcon B Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/42 (0%)
    Other (Not Including Serious) Adverse Events
    Fanfilcon A Toric Lotrafilcon B Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/42 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Investigator cannot publish / present data without prior consent from CooperVision.

    Results Point of Contact

    Name/Title Jose A. Vega, O.D., MSc., FAAO
    Organization CooperVision
    Phone 19256213761
    Email jvega2@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03418064
    Other Study ID Numbers:
    • EX-MKTG-90
    First Posted:
    Feb 1, 2018
    Last Update Posted:
    Nov 13, 2019
    Last Verified:
    Oct 1, 2019