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Completed

NCT Number: NCT01526902

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Optics Research Lab, Indiana University,

Bloomington, Indiana, 47405, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

omafilcon A / PC 1-D MF

Device

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 names: Proclear Multifocal daily wear soft contact lenses

lotrafilcon B / Air Optix MF

Device

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 names: Air OPtix Aqua Multifocal extended wear soft contact lenses

Primary outcomes

  1. Objective Vision Assessments: High Contrast Distance Visual Acuity

    Time frame: After 1 hour of lens wear

    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.

  2. Objective Vision Assessments: High Contrast Intermediate Visual Acuity

    Time frame: After 1 hour of lens wear

    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.

  3. Objective Vision Assessments: High Contrast Near Visual Acuity

    Time frame: After 1 hour of lens wear

    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.

Secondary outcomes

  1. Subjective Overall Vision: High Contrast Distance Visual Quality

    Time frame: After 1 hour of lens wear

    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.

  2. Subjective Vision Assessments: High Contrast Intermediate Visual Quality

    Time frame: After 1 hour of lens wear

    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.

  3. Subjective Vision Assessments: High Contrast Near Visual Quality

    Time frame: After 1 hour of lens wear

    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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2012
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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