BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bioclean First Care EX / comfilcon A
Aosept Clearcare / comfilcon A
Sponsored by
About this trial
This is an interventional other 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
- 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.
Sites / Locations
- Kokama Eye Clinic
- Higashihara Clinic
- Dougenzaka Ioti Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bioclean First Care EX combo, then Aosept Clearcare combo
Aosept Clearcare combo, then Bioclean First Care EX combo
Arm Description
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
Outcomes
Primary Outcome Measures
Ocular Health - Corneal Staining
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Conjunctival Redness
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Limbal Redness
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Papillary Conjunctivitis
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Secondary Outcome Measures
Stinging Sensation Right After Insertion (Subjective Rating)
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Burning Sensation Right After Insertion (Subjective Rating)
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02196766
Brief Title
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Official Title
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioclean First Care EX combo, then Aosept Clearcare combo
Arm Type
Active Comparator
Arm Description
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Arm Title
Aosept Clearcare combo, then Bioclean First Care EX combo
Arm Type
Active Comparator
Arm Description
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
Intervention Type
Other
Intervention Name(s)
Bioclean First Care EX / comfilcon A
Intervention Description
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
Intervention Type
Other
Intervention Name(s)
Aosept Clearcare / comfilcon A
Intervention Description
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
Primary Outcome Measure Information:
Title
Ocular Health - Corneal Staining
Description
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Conjunctival Redness
Description
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Limbal Redness
Description
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Papillary Conjunctivitis
Description
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Stinging Sensation Right After Insertion (Subjective Rating)
Description
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time Frame
Baseline
Title
Burning Sensation Right After Insertion (Subjective Rating)
Description
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taku Muraoka, OD
Organizational Affiliation
Director Professional Services, CVI Japan
Official's Role
Study Director
Facility Information:
Facility Name
Kokama Eye Clinic
City
Joyo-shi
State/Province
Kyoto-fu
ZIP/Postal Code
610-0121
Country
Japan
Facility Name
Higashihara Clinic
City
Kameoka
State/Province
Kyoto-fu
ZIP/Postal Code
621-0861
Country
Japan
Facility Name
Dougenzaka Ioti Eye Clinic
City
Shibuya-ku
State/Province
Tokyo-to
ZIP/Postal Code
150-0043
Country
Japan
12. IPD Sharing Statement
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BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
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