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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
  Purpose

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


Condition Intervention
Presbyopia
Device: omafilcon A / PC 1-D MF
Device: lotrafilcon B / Air Optix MF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Proclear 1-D Multifocal Nondispensing Study

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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: 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.

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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526902

Locations
United States, Indiana
Clinical Optics Research Lab, Indiana University,
Bloomington,, Indiana, United States, 47405
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Peter Kollbaum, OD, PhD Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01526902     History of Changes
Other Study ID Numbers: CV-12-02A
Study First Received: February 2, 2012
Results First Received: November 1, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
contact lenses

Additional relevant MeSH terms:
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 24, 2014