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Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

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.
 
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 )

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE May 28, 2009
Results First Submitted Date  ICMJE September 16, 2010
Results First Posted Date  ICMJE October 29, 2010
Last Update Posted Date June 29, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
visual acuity (distance, intermediate, and near), near range of clear vision, visual ratings (near, night, overall, and visual transition), overall satisfaction, lens preference [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
  • visual ratings (distance, intermediate, computer, and eye fatigue) [ Time Frame: 2 weeks ]
  • percentage of subjects fit with the first pair of lenses [ Time Frame: 2 weeks ]
  • investigator ease of fit [ Time Frame: 2 weeks ]
  • purchase intent [ Time Frame: 2 weeks ]
  • ghosting ratings [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Official Title  ICMJE Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Brief Summary The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Device: Lotrafilcon B
    Silicone hydrogel, soft, multifocal contact lens
  • Device: Senofilcon A
    Silicone hydrogel, soft, multifocal contact lens
Study Arms  ICMJE
  • Lotrafilcon B / Senofilcon A
    Lotrafilcon B, followed by Senofilcon A
    Interventions:
    • Device: Lotrafilcon B
    • Device: Senofilcon A
  • Senofilcon A / Lotrafilcon B
    Senofilcon A, followed by Lotrafilcon B
    Interventions:
    • Device: Lotrafilcon B
    • Device: Senofilcon A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2010)
259
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2009)
260
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00909792
Other Study ID Numbers  ICMJE P-319-C-013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research ( CIBA VISION )
Study Sponsor  ICMJE CIBA VISION
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date January 2012

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