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

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ClinicalTrials.gov Identifier: NCT02537730
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : September 20, 2016
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

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

Condition or disease Intervention/treatment Phase
Myopia Device: Bioclean MPS VII Device: Aosept Clearcare Device: comfilcon A Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Bioclean MPS VII
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system

Device: comfilcon A
contact lens
Other Name: Biofinity
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: Aosept Clearcare
Hydrogen Peroxide Disinfecting and Cleaning system

Device: comfilcon A
contact lens
Other Name: Biofinity


Outcome Measures
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Primary Outcome Measures :
  1. Ocular Health - Corneal Staining [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Comfort [ Time Frame: 1 week ]
    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.

  2. Dryness [ Time Frame: 1 week ]
    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.

  3. Stinging and Burning Sensation [ Time Frame: Baseline ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537730


Locations
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Japan
Kodama Eye Clinic
Joyo-shi, Kyoto-fu, Japan, 610-0121
Higashihara Eye Clinic
Kameoka, Kyoto-fu, Japan, 621-0861
Iwasaki Eye Clinic
Osaka-shi, Osaka-fu, Japan, 542-0082
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Yuji Kodama, MD, PhD Kodama Eye Clinic
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02537730    
Other Study ID Numbers: CVJ-EX-MKTG-1318
First Posted: September 2, 2015    Key Record Dates
Results First Posted: September 20, 2016
Last Update Posted: August 18, 2020
Last Verified: August 2020

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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
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases