Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
NCT ID: NCT01614600
Last Updated: 2013-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2012-06-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DAILIES® AquaComfort Plus®
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Nelfilcon A contact lenses
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Interventions
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Nelfilcon A contact lenses
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Identified as symptomatic using a baseline screening questionnaire.
* Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers \</= 0.75D and no ADD correction.
* Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
* Willing and able to follow instructions and maintain the appointment schedule.
Exclusion Criteria
* Requires monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* A history of ocular surgery/trauma within the last 6 months.
* Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Jami Kern, MBA, PhD
Role: STUDY_DIRECTOR
Alcon Research
Countries
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Other Identifiers
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A00849
Identifier Type: -
Identifier Source: org_study_id