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Comparison of Two New Silicone Hydrogel Multifocal Products

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ClinicalTrials.gov Identifier: NCT00823615
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : October 29, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
The purpose of this trial is to compare the performance of two multifocal contact lenses.

Condition or disease Intervention/treatment
Presbyopia Device: Lotrafilcon B multifocal contact lens Device: Senofilcon A multifocal contact lens

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two New Silicone Hydrogel Multifocal Products
Study Start Date : December 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.



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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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00823615     History of Changes
Other Study ID Numbers: P-319-C-005 sub 7
First Posted: January 15, 2009    Key Record Dates
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