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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: comfilcon A; Device: Bioclean MPS VII; Device: Aosept Clearcare

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kyoto-fu
    • Joyo-shi, Kyoto-fu, Japan, 610-0121
      • Kodama Eye Clinic
    • Kameoka, Kyoto-fu, Japan, 621-0861
      • Higashihara Eye Clinic
  • Osaka-fu
    • Osaka-shi, Osaka-fu, Japan, 542-0082
      • Iwasaki Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Yuji Kodama, MD, PhD, Kodama Eye Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CVJ-EX-MKTG-1318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes