Text Size

Multifocal NonDispensing Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01526902
First received: February 2, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  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 multifocal
Device: lotrafilcon B multifocal

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:

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

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omafilcon A/lotrafilcon B
omafilcon A soft contact lens worn 1st then cross over and subject wears the lotrafilcon B lens 2nd.
 Device: omafilcon A multifocal
Omafilcon A 1-D multifocal daily wear soft contact lens
Device: lotrafilcon B multifocal
Lotrafilcon B multifocal extended wear soft contact lens
Active Comparator: lotrafilcon B/ omafilcon A
lotrafilcon B soft contact lens worn 1st then cross over and subject wears the omafilcon A lens 2nd.
 Device: omafilcon A multifocal
Omafilcon A 1-D multifocal daily wear soft contact lens
Device: lotrafilcon B multifocal
Lotrafilcon B multifocal extended wear soft contact lens

  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
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
Last Updated: April 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
contact lenses

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013