Clinical Trial of Several Contact Lenses in Extended Wear

Study Overview
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Brief Summary
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The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Conditions
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Myopia

Intervention / Treatment
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* Device: senofilcon A
* Device: lotrafilcon A
* Device: lotrafilcon B
* Device: balafilcon A
* Device: comfilcon A
* Device: etafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age, and be between 18 and 39 years of age. Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space. Require a visual correction in both eyes (Monovision not allowed) Require a soft contact lens spherical correction between -0.50 and -9.00D. Have an astigmatic correction less than 1.50D in both eyes. Be able to wear the lens powers available for this study. Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week) Be correctable to a visual acuity of 20/30 or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection. No clinically significant slit lamp findings No other active ocular disease. No previous ocular surgery. Exclusion Criteria: Requires concurrent ocular medication. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear. Diabetic. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). PMMA or RGP lens wear in the previous 8 weeks. Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. Abnormal lacrimal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrollment only. Participation in any concurrent clinical trial. Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related). Has had an eye injury or surgery within the last eight weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A contact lens<br>ACUVUE OASYS | Device: senofilcon A<br>* 1 week extended wear contact lens<br>|
| Active Comparator: lotrafilcon A contact lens<br>NIGHT&DAY | Device: lotrafilcon A<br>* 1 week extended wear contact lens<br>|
| Active Comparator: lotrafilcon B contact lens<br>O2Optix | Device: lotrafilcon B<br>* 1 week extended wear contact lens<br>|
| Active Comparator: balafilcon A contact lens<br>PureVision | Device: balafilcon A<br>* 1 week extended wear contact lens<br>|
| Active Comparator: comfilcon A contact lens<br>Biofinity | Device: comfilcon A<br>* 1 week extended wear contact lens<br>|
| Active Comparator: etafilcon A contact lens<br>ACUVUE 2 | Device: etafilcon A<br>* 1 week extended wear contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Corneal Infiltrative Events | Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | 52 weeks | 
| Incidence of Adverse Events | Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | 52 weeks |