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 24, 2014
Last verified: November 2014
  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: Dispense (Day 1), Hour 9 ] [ Designated as safety issue: No ]
    Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.


Secondary Outcome Measures:
  • HC/HI Binocular VA at Distance [ Time Frame: Dispense (Day 1), Hour 9 ] [ Designated as safety issue: No ]
    Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

  • Over-refraction (OR) Monocular at Distance [ Time Frame: Dispense (Day 1), Hour 9 ] [ Designated as safety issue: No ]
    OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.


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 MF, then AOAMF
Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 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 with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
Other Name: AIR OPTIX® AQUA MULTIFOCAL
AOAMF, then Delefilcon A MF
Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 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 with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
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.
  • 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 (only 1 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
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: NCT01951573

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Joachim Nick, Dipl. Ing. CIBA VISION GmbH
  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
Results First Received: November 24, 2014
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 03, 2015