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Comparison of Two New Silicone Hydrogel Multifocal Products

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823615
First Posted: January 15, 2009
Last Update Posted: June 29, 2012
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.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The purpose of this trial is to compare the performance of two multifocal contact lenses.

Condition Intervention
Presbyopia Device: Lotrafilcon B multifocal contact lens Device: Senofilcon A multifocal contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two New Silicone Hydrogel Multifocal Products

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ]
    Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in 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.

  • Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [ Time Frame: After 1 week of wear ]
    Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in 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.


Enrollment: 40
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lotrafilcon B / Senofilcon A
Lotrafilcon B, followed by Senofilcon A
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Senofilcon A multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Senofilcon A / Lotrafilcon B
Senofilcon A, followed by Lotrafilcon B
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Senofilcon A multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 35 years of age
  • Best-corrected visual acuity of at least 20/40 in each eye.
  • Spectacle add between +0.75D and +1.50D (inclusive).
  • Able to be fit in available study sphere powers (-0.50 to -5.50D).
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic Clinical Trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Previous refractive surgery.
  • Astigmatism > 1.00D.
  • Currently wearing ACUVUE OASYS for PRESBYOPIA.
  • Other protocol inclusion/exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00823615     History of Changes
Other Study ID Numbers: P-319-C-005 sub 7
First Submitted: January 13, 2009
First Posted: January 15, 2009
Results First Submitted: September 7, 2010
Results First Posted: October 29, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases