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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Aosept Clearcare; Device: Bioclean MPS VII; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537730

CVJ-EX-MKTG-1318

Details and patient eligibility

About

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

Full description

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).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Bioclean MPS VII / comfilcon A combination

Active Comparator group

Description:

Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.

Treatment:

Device: comfilcon A

Device: Bioclean MPS VII

Aosept Clearcare / comfilcon A combination

Active Comparator group

Description:

Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.

Treatment:

Device: comfilcon A

Device: Aosept Clearcare