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Multifocal Lens Design Evaluation

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ClinicalTrials.gov Identifier: NCT01997216
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

Condition or disease Intervention/treatment Phase
Refractive Error Presbyopia Device: Delefilcon A multifocal contact lens Device: Lotrafilcon B multifocal contact lens Not Applicable

Detailed Description:
Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Multifocal Lens Design Evaluation (US)
Study Start Date : October 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Delefilcon A MF, then AOAMF
Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
Device: Delefilcon A multifocal contact lens
Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Device: Lotrafilcon B multifocal contact lens
Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
Other Names:
  • AIR OPTIX® AQUA MULTIFOCAL
  • AOAMF

AOAMF, then Delefilcon A MF
Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
Device: Delefilcon A multifocal contact lens
Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Device: Lotrafilcon B multifocal contact lens
Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
Other Names:
  • AIR OPTIX® AQUA MULTIFOCAL
  • AOAMF




Primary Outcome Measures :
  1. Mean Binocular HC/HI Visual Acuity at Near (40 cm) [ Time Frame: Up to Hour 9 ]
    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 equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.


Secondary Outcome Measures :
  1. Mean Binocular HC/HI Visual Acuity at Distance [ Time Frame: Up to Hour 9 ]
    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 equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.

  2. Mean Monocular Over-refraction (OR) at Distance [ Time Frame: Up to Hour 9 ]
    OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign written Informed Consent document.
  • Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
  • Be presbyopic with a spectacle add ≥ 0.50 diopter.
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • Eye injury or surgery within 12 weeks of enrollment in this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
  • Binocular visual acuity worse than 20/25.
  • Corrected by monovision.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997216


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Joachim Nick, Dipl.-Ing Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01997216     History of Changes
Other Study ID Numbers: C-12-036
First Posted: November 28, 2013    Key Record Dates
Results First Posted: February 4, 2014
Last Update Posted: February 4, 2014
Last Verified: December 2013
Keywords provided by Alcon Research:
contact lenses
multifocal
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases