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Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens

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ClinicalTrials.gov Identifier: NCT00886119
Recruitment Status : Completed
First Posted : April 22, 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 the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B multifocal contact lens Device: Omafilcon A multifocal contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds
Study Start Date : April 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Lotrafilcon B / Omafilcon A
Lotrafilcon B, followed by Omafilcon A
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Omafilcon A multifocal contact lens
Hydrogel, soft, multifocal contact lens for daily wear use
Omafilcon A / Lotrafilcon B
Omafilcon A, followed by Lotrafilcon B
Device: Lotrafilcon B multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Device: Omafilcon A multifocal contact lens
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.



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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:

  • Be at least 35 years of age.
  • Best-corrected visual acuity of at least 20/40 in each eye.
  • Spectacle add from +1.50D and +2.50D (inclusive).
  • Able to be fit in available study sphere powers (Plano to -4.00D).
  • 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 Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
  • Other protocol inclusion / exclusion criteria may apply.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00886119     History of Changes
Other Study ID Numbers: P-319-C-005 sub 8
First Posted: April 22, 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