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Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses
Hydrogen peroxide-based lens care solution
Saline solution for rinsing contact lenses
Saline solution for rinsing contact lens case
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Error

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must sign Informed Consent Document;
  • Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
  • Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
  • Willing to answer text messages on a daily basis during the study;
  • Willing to discontinue artificial tears and rewetting drops on the days of study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
  • Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
  • History of herpetic keratitis, corneal surgery or irregular cornea;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Pregnant or lactating;
  • Participation in any clinical study within 30 days of Visit 1;
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    AOHG, then AOA

    AOA, then AOHG

    Arm Description

    Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.

    Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.

    Outcomes

    Primary Outcome Measures

    Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
    Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.

    Secondary Outcome Measures

    Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
    The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
    Change From Insertion in Minimum Protected Area (MPA)
    MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.

    Full Information

    First Posted
    March 1, 2016
    Last Updated
    May 31, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02699684
    Brief Title
    Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
    Official Title
    One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 12, 2016 (Actual)
    Primary Completion Date
    October 20, 2016 (Actual)
    Study Completion Date
    October 20, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
    Detailed Description
    Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    AOHG, then AOA
    Arm Type
    Other
    Arm Description
    Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
    Arm Title
    AOA, then AOHG
    Arm Type
    Other
    Arm Description
    Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lenses with EOBO-41
    Other Intervention Name(s)
    AIR OPTIX® plus HYDRAGLYDE®, AOHG
    Intervention Description
    Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lenses
    Other Intervention Name(s)
    AIR OPTIX® AQUA, AOA
    Intervention Description
    Lotrafilcon B contact lenses packaged with copolymer 845
    Intervention Type
    Device
    Intervention Name(s)
    Hydrogen peroxide-based lens care solution
    Other Intervention Name(s)
    AOSEPT® PLUS, CLEAR CARE® PLUS
    Intervention Description
    Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Saline solution for rinsing contact lenses
    Other Intervention Name(s)
    Minims®
    Intervention Description
    Commercially-available saline solution used as needed
    Intervention Type
    Device
    Intervention Name(s)
    Saline solution for rinsing contact lens case
    Other Intervention Name(s)
    LENS PLUS® OCUPURE™
    Intervention Description
    Commercially-available solution used as needed
    Primary Outcome Measure Information:
    Title
    Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
    Description
    Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
    Time Frame
    Day 30, each product
    Secondary Outcome Measure Information:
    Title
    Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
    Description
    The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
    Time Frame
    Day 30, each product
    Title
    Change From Insertion in Minimum Protected Area (MPA)
    Description
    MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
    Time Frame
    Hour 0 (Lens Insertion) to Hour 12 on Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must sign Informed Consent Document; Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye; Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range; Willing to answer text messages on a daily basis during the study; Willing to discontinue artificial tears and rewetting drops on the days of study visits; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week); Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current); History of herpetic keratitis, corneal surgery or irregular cornea; Any use of systemic or ocular medications for which contact lens wear could be contraindicated; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Pregnant or lactating; Participation in any clinical study within 30 days of Visit 1; Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trial Manager, EMEA
    Organizational Affiliation
    Alcon, A Novartis Division
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

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