ClinicalTrials.gov
ClinicalTrials.gov Menu

Proclear 1-D Multifocal Nondispensing Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01526902
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : March 6, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

Condition or disease Intervention/treatment Phase
Presbyopia Device: omafilcon A / PC 1-D MF Device: lotrafilcon B / Air Optix MF Not Applicable

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).

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Proclear 1-D Multifocal Nondispensing Study
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01526902     History of Changes
Other Study ID Numbers: CV-12-02A
First Posted: February 6, 2012    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: April 7, 2014
Last Verified: March 2014

Keywords provided by Coopervision, Inc.:
contact lenses

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases