Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
NCT ID: NCT00940459
Last Updated: 2016-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2009-06-30
2009-09-30
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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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Acuvue Oasys
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Senofilcon A contact lens (Acuvue Oasys)
Silicone hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Biofinity
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Air Optix
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Lotrafilcon B contact lens (Air Optix)
Silicone hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
PureVision
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Balafilcon A contact lens (PureVision)
Silicone hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Acuvue 2
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Etafilcon A contact lens (Acuvue 2)
Hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Interventions
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Senofilcon A contact lens (Acuvue Oasys)
Silicone hydrogel contact lens CE-marked for the intended usage.
Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens CE-marked for the intended usage.
Lotrafilcon B contact lens (Air Optix)
Silicone hydrogel contact lens CE-marked for the intended usage.
Balafilcon A contact lens (PureVision)
Silicone hydrogel contact lens CE-marked for the intended usage.
Etafilcon A contact lens (Acuvue 2)
Hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adapted contact lens wearer
* Sign informed consent
* Normal eyes with the exception of the need for visual correction
* Astigmatism less than or equal to -0.75 diopter
* Spherical prescription range between -10.00 and +6.00 diopters
Exclusion Criteria
* Monocular vision
* Lid or conjunctival infections or abnormalities
* Conjunctival staining greater than Grade 1
* Corneal staining greater than Grade 2
* Corneal edema or opacifications
* Aphakia
* Any previous corneal surgery
* Iritis
* Recent significant changes in visual acuity
* Ocular disease that contraindicates contact lens wear
* Tarsal abnormalities greater than Grade 2
* Any ophthalmic medication
* Any systemic medication or condition that might affect the subject's participation in the study
* Chronic upper respiratory infections or colds
* Pregnancy or planning to become pregnant
* Lactation
* Seasonal allergies
* Known infections or immunosuppressive disease
* Participation in other studies
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Optometric Technology Group Ltd
London, , United Kingdom
Countries
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References
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Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.
Other Identifiers
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M-09-11
Identifier Type: -
Identifier Source: org_study_id