Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
NCT ID: NCT01548833
Last Updated: 2013-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2012-03-31
2012-04-30
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
SINGLE
Study Groups
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Dailies Total 1
Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
TruEye
Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Clariti
Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.
Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Interventions
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Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require vision correction in both eyes.
* Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
* Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
* Willing and able to wear study contact lenses 16 hours per day.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
Exclusion Criteria
* Require monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotic use within 7 days of enrollment.
* Topical ocular or systemic corticosteroid use within 14 days of enrollment.
* Pregnant and nursing women.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
18 Years
ALL
No
Sponsors
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Aston University
OTHER
Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Jami Kern, PhD
Role: STUDY_DIRECTOR
Alcon Research
Other Identifiers
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A00924
Identifier Type: -
Identifier Source: org_study_id
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