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Comparison of Two New Silicone Hydrogel Multifocal Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00823615
First received: January 13, 2009
Last updated: June 26, 2012
Last verified: January 2012

January 13, 2009
June 26, 2012
December 2008
February 2009   (final data collection date for primary outcome measure)
  • Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Measure: subject comfort ratings, visual ratings, purchase intent, lens preference [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823615 on ClinicalTrials.gov Archive Site
Not Provided
visual acuity (distance, intermediate, and near) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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Comparison of Two New Silicone Hydrogel Multifocal Products
Comparison of Two New Silicone Hydrogel Multifocal Products

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Presbyopia
  • 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
  • Lotrafilcon B / Senofilcon A
    Lotrafilcon B, followed by Senofilcon A
    Interventions:
    • Device: Lotrafilcon B multifocal contact lens
    • Device: Senofilcon A multifocal contact lens
  • Senofilcon A / Lotrafilcon B
    Senofilcon A, followed by Lotrafilcon B
    Interventions:
    • Device: Lotrafilcon B multifocal contact lens
    • Device: Senofilcon A multifocal contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00823615
P-319-C-005 sub 7
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP