Proclear 1-D Multifocal Nondispensing Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01526902
First received: February 2, 2012
Last updated: March 7, 2014
Last verified: March 2014

February 2, 2012
March 7, 2014
February 2012
May 2012   (final data collection date for primary outcome measure)
  • Objective Vision Assessments: High Contrast Distance Visual Acuity [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
  • Objective Vision Assessments: High Contrast Intermediate Visual Acuity [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
  • Objective Vision Assessments: High Contrast Near Visual Acuity [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Visual Acuity [ Time Frame: after 1 hour of wear ] [ Designated as safety issue: No ]
Tested with reading charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is 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 than baseline 20/20 value.
Complete list of historical versions of study NCT01526902 on ClinicalTrials.gov Archive Site
  • Subjective Overall Vision: High Contrast Distance Visual Quality [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
  • Subjective Vision Assessments: High Contrast Intermediate Visual Quality [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
  • Subjective Vision Assessments: High Contrast Near Visual Quality [ Time Frame: After 1 hour of lens wear ] [ Designated as safety issue: No ]
    Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Not Provided
Not Provided
Not Provided
 
Proclear 1-D Multifocal Nondispensing Study
Proclear 1-D Multifocal Nondispensing Study

This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Presbyopia
  • Device: omafilcon A / PC 1-D MF
    Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
    Other Name: Proclear Multifocal daily wear soft contact lenses
  • Device: lotrafilcon B / Air Optix MF
    Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
    Other Name: Air OPtix Aqua Multifocal extended wear soft contact lenses
  • Active Comparator: omafilcon A / PC 1-D MF

    omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)

    Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

    Interventions:
    • Device: omafilcon A / PC 1-D MF
    • Device: lotrafilcon B / Air Optix MF
  • Active Comparator: lotrafilcon B / Air Optix MF

    lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)

    Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

    Interventions:
    • Device: omafilcon A / PC 1-D MF
    • Device: lotrafilcon B / Air Optix MF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be between 40 and 65 years of age (inclusive)
  • Require a reading addition of +1.25 to +2.50D (inclusive)
  • Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
  • Spectacle cylinder less than or equal to 0.75D in both eyes.
  • Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
  • Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
  • Have a minimum 2 weeks soft contact lens experience
  • Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
  • Able to read, comprehend and sign an informed consent
  • Willing to comply with the wear and study visit schedule
  • Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
  • No gas permeable contact lens wear for 1 month prior to the study

Exclusion Criteria:

To be eligible for the study, each candidate must not present with any of the following

  • Any active corneal infection, injury, inflammation, or ocular abnormality
  • Systemic or ocular allergies, which might interfere with contact lens wear
  • Systemic disease, which might interfere with contact lens wear
  • Ocular disease, which might interfere with contact lens wear
  • Pregnant or lactating
  • Strabismus/amblyopia
  • Habitually uncorrected anisometropia greater than or equal to 2.00 D
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01526902
CV-12-02A
No
Coopervision, Inc.
Coopervision, Inc.
Not Provided
Principal Investigator: Peter Kollbaum, OD, PhD Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
Coopervision, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP