We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909792
First Posted: May 28, 2009
Last Update Posted: June 29, 2012
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.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Condition Intervention
Presbyopia Device: Lotrafilcon B Device: Senofilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • 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.


Enrollment: 259
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00909792     History of Changes
Other Study ID Numbers: P-319-C-013
First Submitted: May 27, 2009
First Posted: May 28, 2009
Results First Submitted: September 16, 2010
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