Clinical Comparison of Silicone Hydrogel Monthly Lenses
NCT ID: NCT03169153
Last Updated: 2019-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2017-09-22
2018-07-19
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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Lotrafilcon B, then senofilcon C
Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Lotrafilcon B contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Senofilcon C, then lotrafilcon B
Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Lotrafilcon B contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Interventions
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Lotrafilcon B contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
* Screening lenses worn 10 hours exhibiting high lipid uptake.
Exclusion Criteria
* Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
* History of herpetic keratitis, corneal surgery, or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Abnormal ocular conditions or findings, as specified in the protocol;
* Known pregnancy and lactation.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Manager, Medical Clinical Trial Services
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Alcon Investigative Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLL541-P001
Identifier Type: -
Identifier Source: org_study_id
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