Myopia Clinical Trial
Official title:
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Verified date | August 2020 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
Status | Completed |
Enrollment | 33 |
Est. completion date | June 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Kodama Eye Clinic | Joyo-shi | Kyoto-fu |
Japan | Higashihara Eye Clinic | Kameoka | Kyoto-fu |
Japan | Iwasaki Eye Clinic | Osaka-shi | Osaka-fu |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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