Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
NCT ID: NCT01561560
Last Updated: 2014-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2012-05-31
2012-08-31
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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DAILIES TOTAL1, then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
TRUEYE, then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Interventions
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Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
* Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least eight hours per day and at least five days per week.
Exclusion Criteria
* Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
* Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last six months.
* Topical ocular or systemic use of antibiotics within seven days of enrollment.
* Pregnant or nursing women.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Camille Girault
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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P-347-C-019
Identifier Type: -
Identifier Source: org_study_id
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