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Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B
Senofilcon A
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • Be at least 35 years of age
  • Best-corrected distance visual acuity of at least 20/40 in each eye.
  • Spectacle add between +0.75D and +1.50D (inclusive).
  • Able to be fit in available study sphere powers (-1.00 to -5.00D)
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Astigmatism ≥ 1.00D.
  • Currently wearing either of the study products.
  • Other protocol inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Lotrafilcon B / Senofilcon A

    Senofilcon A / Lotrafilcon B

    Arm Description

    Lotrafilcon B, followed by Senofilcon A

    Senofilcon A, followed by Lotrafilcon B

    Outcomes

    Primary Outcome Measures

    Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
    Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2009
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00909792
    Brief Title
    Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
    Official Title
    Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIBA VISION

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    259 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lotrafilcon B / Senofilcon A
    Arm Type
    Other
    Arm Description
    Lotrafilcon B, followed by Senofilcon A
    Arm Title
    Senofilcon A / Lotrafilcon B
    Arm Type
    Other
    Arm Description
    Senofilcon A, followed by Lotrafilcon B
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B
    Intervention Description
    Silicone hydrogel, soft, multifocal contact lens
    Intervention Type
    Device
    Intervention Name(s)
    Senofilcon A
    Intervention Description
    Silicone hydrogel, soft, multifocal contact lens
    Primary Outcome Measure Information:
    Title
    Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
    Description
    Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
    Time Frame
    After 1 week of wear

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be at least 35 years of age Best-corrected distance visual acuity of at least 20/40 in each eye. Spectacle add between +0.75D and +1.50D (inclusive). Able to be fit in available study sphere powers (-1.00 to -5.00D) Currently wearing soft contact lenses at least 5 days a week. Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Astigmatism ≥ 1.00D. Currently wearing either of the study products. Other protocol inclusion/exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

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