Back to resultsBIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bioclean MPS VII
Aosept Clearcare
comfilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility 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
Sites / Locations
- Kodama Eye Clinic
- Higashihara Eye Clinic
- Iwasaki Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bioclean MPS VII / comfilcon A combination
Aosept Clearcare / comfilcon A combination
Arm Description
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02537730
Brief Title
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Official Title
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioclean MPS VII / comfilcon A combination
Arm Type
Active Comparator
Arm Description
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Arm Title
Aosept Clearcare / comfilcon A combination
Arm Type
Active Comparator
Arm Description
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Intervention Type
Device
Intervention Name(s)
Bioclean MPS VII
Intervention Description
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
Intervention Type
Device
Intervention Name(s)
Aosept Clearcare
Intervention Description
Hydrogen Peroxide Disinfecting and Cleaning system
Intervention Type
Device
Intervention Name(s)
comfilcon A
Other Intervention Name(s)
Biofinity
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Ocular Health - Corneal Staining
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Comfort
Description
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.
Time Frame
1 week
Title
Dryness
Description
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.
Time Frame
1 week
Title
Stinging and Burning Sensation
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Kodama, MD, PhD
Organizational Affiliation
Kodama Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kodama Eye Clinic
City
Joyo-shi
State/Province
Kyoto-fu
ZIP/Postal Code
610-0121
Country
Japan
Facility Name
Higashihara Eye Clinic
City
Kameoka
State/Province
Kyoto-fu
ZIP/Postal Code
621-0861
Country
Japan
Facility Name
Iwasaki Eye Clinic
City
Osaka-shi
State/Province
Osaka-fu
ZIP/Postal Code
542-0082
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
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