Evaluation of a New Daily Disposable Multifocal Contact Lens Design

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01951573
First received: September 24, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).


Condition Intervention
Presbyopia
Hyperopia
Refractive Error
Device: Delefilcon A multifocal contact lenses
Device: Lotrafilcon B multifocal contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Delefilcon A Multifocal Plus Power Lens Design Evaluation

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • High contrast/high illumination (HC/HI) binocular visual acuity (VA) at near [ Time Frame: Up to Hour 9 ] [ Designated as safety issue: No ]
    HC/HI binocular VA at near (40 centimeters) will be collected in logarithm of the Minimal Angle of Resolution (logMAR).


Secondary Outcome Measures:
  • HC/HI binocular VA at distance [ Time Frame: Up to Hour 9 ] [ Designated as safety issue: No ]
    HC/HI binocular VA at distance (equivalent to 6 meters) will be collected in logMAR.

  • Over-refraction (OR) monocular at distance [ Time Frame: Up to Hour 9 ] [ Designated as safety issue: No ]
    OR is the amount of additional correction needed to improve VA. OR at distance (equivalent to 6 meters) will be collected in diopters (D).


Enrollment: 36
Study Start Date: October 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delefilcon A Multifocal, then AOAMF
Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product will be worn bilaterally (ie, in both eyes) for 9 hours, with a 1-8 day washout separating the two wear periods.
Device: Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
Device: Lotrafilcon B multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear and extended wear use up to 4 weeks
Other Name: AIR OPTIX® AQUA MULTIFOCAL
AOAMF, then Delefilcon A Multifocal
Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product will be worn bilaterally (ie, in both eyes) for 9 hours, with a 1-8 day washout separating the two wear periods.
Device: Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
Device: Lotrafilcon B multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear and extended wear use up to 4 weeks
Other Name: AIR OPTIX® AQUA MULTIFOCAL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with normal eyes who are not using any ocular medication.
  • Must sign the Informed Consent document.
  • Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
  • Manifest cylinder less than or equal to 0.75D.
  • Best corrected distance VA greater than or equal to 20/25 in each eye.
  • Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
  • Be presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
  • Any use of systemic or ocular medications for which CL wear could be contraindicated.
  • History of herpetic keratitis.
  • History of refractive surgery or irregular cornea.
  • A clinically significant dry eye that precludes CL wear.
  • Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
  • Monocular subjects (only one eye with functional vision).
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01951573

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Joachim Nick, Dipl. Ing. Alcon Research
Principal Investigator: Teresa DeCenzo-Verbeten, O.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01951573     History of Changes
Other Study ID Numbers: C-13-011
Study First Received: September 24, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
contact lenses
multifocal
daily disposable
silicone hydrogel
presbyopia

Additional relevant MeSH terms:
Hyperopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014