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Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

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ClinicalTrials.gov Identifier: NCT00909792
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : October 29, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Description
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Brief Summary:
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B Device: Senofilcon A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Study Start Date : May 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
Lotrafilcon B / Senofilcon A
Lotrafilcon B, followed by Senofilcon A
 Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens

Device: Senofilcon A
Silicone hydrogel, soft, multifocal contact lens
Senofilcon A / Lotrafilcon B
Senofilcon A, followed by Lotrafilcon B
 Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens

Device: Senofilcon A
Silicone hydrogel, soft, multifocal contact lens


Outcome Measures
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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.


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

Inclusion Criteria:

  • Be at least 35 years of age
  • Best-corrected distance 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 (-1.00 to -5.00D)
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • 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.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Astigmatism ≥ 1.00D.
  • Currently wearing either of the study products.
  • Other protocol inclusion/exclusion criteria may apply.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00909792     History of Changes
Other Study ID Numbers: P-319-C-013
First Posted: May 28, 2009    Key Record Dates
Results First Posted: October 29, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases