BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

NCT ID: NCT02196766

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-08-31

Brief Summary

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

Detailed Description

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

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Bioclean First Care EX combo, then Aosept Clearcare combo

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

Group Type: ACTIVE_COMPARATOR

Bioclean First Care EX / comfilcon A

Intervention Type: OTHER

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

Aosept Clearcare / comfilcon A

Intervention Type: OTHER

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.

Aosept Clearcare combo, then Bioclean First Care EX combo

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

Group Type: ACTIVE_COMPARATOR

Bioclean First Care EX / comfilcon A

Intervention Type: OTHER

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

Aosept Clearcare / comfilcon A

Intervention Type: OTHER

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.

Interventions

Bioclean First Care EX / comfilcon A

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

Intervention Type: OTHER

Aosept Clearcare / comfilcon A

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taku Muraoka, OD

Role: STUDY_DIRECTOR

Director Professional Services, CVI Japan

Locations

Kokama Eye Clinic

Joyo-shi, Kyoto, Japan

Higashihara Clinic

Kameoka, Kyoto, Japan

Dougenzaka Ioti Eye Clinic

Shibuya-ku, Tokyo-to, Japan

Countries

Japan

Other Identifiers

CVJ-EX-MKTG-1818

Identifier Type: -

Identifier Source: org_study_id