BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Other: Aosept Clearcare / comfilcon A; Other: Bioclean First Care EX / comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02196766

CVJ-EX-MKTG-1818

Details and patient eligibility

About

To determine if patients are unreactive to the lens care solution / Biofinity combination.

Full description

To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.

Enrollment: 30 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
• Is currently an adapted spherical soft CL wearer
• Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
• Has less than 1.00D 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 information consent letter.
• Is willing to comply with the wear schedule (at least 40 hrs per week)
• Is willing to comply with the visit schedule

Exclusion criteria

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has a CL prescription outside the range of - 0.25 to -12.00D
• Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
• Has best corrected spectacle distance vision worse than 20/20 in either 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 severe 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.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Bioclean First Care EX combo, then Aosept Clearcare combo

Active Comparator group

Description:

Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.

Treatment:

Other: Aosept Clearcare / comfilcon A

Other: Bioclean First Care EX / comfilcon A

Aosept Clearcare combo, then Bioclean First Care EX combo

Active Comparator group

Description:

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.

Treatment:

Other: Aosept Clearcare / comfilcon A

Other: Bioclean First Care EX / comfilcon A