Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
NCT ID: NCT01362907
Last Updated: 2012-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2011-05-31
2011-06-30
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
NONE
Study Groups
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Delefilcon A / etafilcon A
Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Delefilcon A contact lens
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lens
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Etafilcon A / delefilcon A
Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Delefilcon A contact lens
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lens
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Interventions
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Delefilcon A contact lens
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lens
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
* Visual acuity with study lenses 20/25 or better.
* Cylinder less than or equal to 0.75 D.
* Currently wearing daily disposable lenses.
Exclusion Criteria
* Any active anterior segment ocular disease that would contraindicate contact lens wear.
* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* Eye injury within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any clinical trial.
ALL
No
Sponsors
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CIBA VISION
INDUSTRY
Responsible Party
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Other Identifiers
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P-347-C-013
Identifier Type: -
Identifier Source: org_study_id