Evaluation of a New Daily Disposable Multifocal Contact Lens Design
NCT ID: NCT01951573
Last Updated: 2014-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2013-10-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
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
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.
Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
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
Interventions
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Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Joachim Nick, Dipl. Ing.
Role: STUDY_DIRECTOR
CIBA VISION GmbH
Other Identifiers
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C-13-011
Identifier Type: -
Identifier Source: org_study_id