Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01371539
First received: June 9, 2011
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.


Condition Intervention
Myopia
Presbyopia
Device: Lotrafilcon B contact lens
Device: Comfilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

  • Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.


Enrollment: 109
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lotrafilcon B / Comfilcon A
Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: Biofinity Multifocal
Comfilcon A / Lotrafilcon B
Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: Biofinity Multifocal

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 35 years of age.
  • Spectacle add of +0.50 to +2.50 diopters (inclusive).
  • Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
  • Able to be fit in both eyes with soft multifocal lenses in available powers.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within 12 weeks of enrollment in trial.
  • Currently enrolled in any clinical trial.
  • Astigmatism of 1.00 diopter or more.
  • Currently wearing excluded brands of multifocal lenses, as specified by protocol.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371539

Sponsors and Collaborators
CIBA VISION
Investigators
Study Director: Stacie Cummings, O.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01371539     History of Changes
Other Study ID Numbers: P-319-C-021
Study First Received: June 9, 2011
Results First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Myopia
Presbyopia

Additional relevant MeSH terms:
Myopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014