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Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Alcon logo

Alcon

Status

Completed

Conditions

Refractive Error
Presbyopia
Hyperopia

Treatments

Device: Delefilcon A multifocal contact lenses
Device: Lotrafilcon B multifocal contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951573
C-13-011

Details and patient eligibility

About

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).

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

36 participants in 2 patient groups

Delefilcon A MF, then AOAMF
Other group
Description:
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.
Treatment:
Device: Delefilcon A multifocal contact lenses
Device: Lotrafilcon B multifocal contact lenses
AOAMF, then Delefilcon A MF
Other group
Description:
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.
Treatment:
Device: Delefilcon A multifocal contact lenses
Device: Lotrafilcon B multifocal contact lenses

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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