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Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

Primary Purpose

Contact Lens Fit, Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 114675A multi-purpose disinfecting solution (MPDS)
renu fresh Multi-Purpose Solution (MPS)
Galyfilcon A contact lenses (Acuvue Advance)
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Contact Lens Fit focused on measuring Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older.
  • History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
  • Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
  • Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
  • History of intolerance or known sensitivity to any component of the treatments.
  • Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    FID 114576A / renu fresh

    renu fresh / FID 114675A

    Arm Description

    FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.

    Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.

    Outcomes

    Primary Outcome Measures

    Lens Fit
    As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.

    Secondary Outcome Measures

    Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
    The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.

    Full Information

    First Posted
    November 10, 2010
    Last Updated
    June 8, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01240135
    Brief Title
    Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
    Official Title
    Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (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 the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contact Lens Fit, Myopia
    Keywords
    Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FID 114576A / renu fresh
    Arm Type
    Other
    Arm Description
    FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
    Arm Title
    renu fresh / FID 114675A
    Arm Type
    Other
    Arm Description
    Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
    Intervention Type
    Device
    Intervention Name(s)
    FID 114675A multi-purpose disinfecting solution (MPDS)
    Other Intervention Name(s)
    Alcon Multi-Purpose Disinfecting Solution (MPDS)
    Intervention Description
    Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
    Intervention Type
    Device
    Intervention Name(s)
    renu fresh Multi-Purpose Solution (MPS)
    Other Intervention Name(s)
    Bausch + Lomb renu® fresh™ Multi-Purpose Solution
    Intervention Description
    Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
    Intervention Type
    Device
    Intervention Name(s)
    Galyfilcon A contact lenses (Acuvue Advance)
    Other Intervention Name(s)
    Acuvue® Advance®
    Intervention Description
    A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
    Primary Outcome Measure Information:
    Title
    Lens Fit
    Description
    As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
    Time Frame
    Day 14 of lens wear
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
    Description
    The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
    Time Frame
    Day 14 of lens wear

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older. History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1. Wear contact lenses a minimum of 8 hours per day prior to Visit 1. Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable. History of intolerance or known sensitivity to any component of the treatments. Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

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