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Complete Easy Rub Comparative Efficacy Study

Primary Purpose

Myopia, Hyperopia, Astigmatism

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complete Easy Rub Formula MPS
Aquify MPS
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
  • Be at least 18 years old, male or female;
  • Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
  • Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
  • Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
  • Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution;

Exclusion Criteria:

  • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
  • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
  • Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
  • Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Easy Rub MPS

    Aquify MPS

    Arm Description

    Complete Easy Rub Formula MPS

    Outcomes

    Primary Outcome Measures

    Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2009
    Last Updated
    June 26, 2017
    Sponsor
    Abbott Medical Optics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01019564
    Brief Title
    Complete Easy Rub Comparative Efficacy Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    March 2010 (Anticipated)
    Study Completion Date
    March 2010 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Optics

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months. The hypotheses for this trial are: Lens cleanliness measures between solutions will be no different. Subjective ratings between solutions will be no different. Ocular response between solutions will be no different.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Hyperopia, Astigmatism

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Easy Rub MPS
    Arm Type
    Experimental
    Arm Description
    Complete Easy Rub Formula MPS
    Arm Title
    Aquify MPS
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Complete Easy Rub Formula MPS
    Intervention Description
    Multi-purpose solution
    Intervention Type
    Device
    Intervention Name(s)
    Aquify MPS
    Intervention Description
    Multi-purpose solution
    Primary Outcome Measure Information:
    Title
    Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; Be at least 18 years old, male or female; Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses; Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses; Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution; Exclusion Criteria: Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study; Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study

    12. IPD Sharing Statement

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