BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Study Overview
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Brief Summary
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Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Detailed Description
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To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).

Official Title
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BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Conditions
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Myopia

Intervention / Treatment
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* Device: Bioclean MPS VII
* Device: Aosept Clearcare
* Device: comfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is over 18 years of age (inclusive) Has had a self-reported visual exam in the last two years Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive) Has less than 1.00 D spectacle cylinder in each eye Is correctable to a visual acuity of 20/20 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the informed consent letter Is willing to comply with the wear schedule (at least 40hrs per week) Is willing to comply with the visit schedule Exclusion Criteria: Has never worn contact lenses before Currently wears rigid gas permeable contact lens Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day) Has a CL prescription outside the range of -0.25D to -12.00D Has a spectacle cylinder greater than -0.75D of cylinder in either eye Has best corrected spectacle distant vision worse than 20/20 in ether eye Has any systemic disease affecting ocular health Is using any systemic or topical medications that will affect ocular health Has any ocular pathology or sever insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars Is aphakic Is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bioclean MPS VII / comfilcon A combination<br>Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. | Device: Bioclean MPS VII<br>* PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system<br>Device: comfilcon A<br>* contact lens<br>* Other names: Biofinity;|
| Active Comparator: Aosept Clearcare / comfilcon A combination<br>Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. | Device: Aosept Clearcare<br>* Hydrogen Peroxide Disinfecting and Cleaning system<br>Device: comfilcon A<br>* contact lens<br>* Other names: Biofinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Health - Corneal Staining | Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. | 1 week | 
| Dryness | Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. | 1 week | 
| Stinging and Burning Sensation | Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all. | Baseline |