Back to resultsClinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Primary Purpose
Myopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
comfilcon A MTO
comfilcon A
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
Exclusion Criteria:
- Has never worn contact lenses before.
- 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 (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Sites / Locations
- CORL, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
comfilcon A MTO
comfilcon A
Arm Description
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
Outcomes
Primary Outcome Measures
Lens Surface Assessment of Study Lenses - Surface Wettability
Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Lens Surface Assessment of Study Lenses - Deposits
Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)
Lens Surface Assessment of Study Lenses - Surface Acceptance
Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Subjective Rating For Comfort - Comfort Since Last Visit
Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Subjective Rating For Comfort Preference
Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Subjective Rating For Handling - Insertion
Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Subjective Rating For Handling - Removal
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
Investigator's Assessment of Stability
Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
General Lens Fit - Fit Acceptance
Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Lens Fitting - Rotation/Mislocation
Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Anterior Ocular Health - Corneal Staining (Central)
Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Nasal)
Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Temporal)
Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - CornealStaining (Superior)
Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Inferior)
Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Conjunctival Staining (Nasal)
Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Superior)
Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Temporal)
Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Inferior)
Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185105
Brief Title
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Official Title
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 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
The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
Detailed Description
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
comfilcon A MTO
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
Arm Title
comfilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
Intervention Type
Device
Intervention Name(s)
comfilcon A MTO
Other Intervention Name(s)
Biofinity Toric MTO
Intervention Description
Randomized to a test lens in one eye and control lens in the other as a matched pair.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Other Intervention Name(s)
Biofinity Toric
Intervention Description
Randomized to a test lens in one eye and control lens in the other as a matched pair.
Primary Outcome Measure Information:
Title
Lens Surface Assessment of Study Lenses - Surface Wettability
Description
Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Time Frame
15min & 6hrs
Title
Lens Surface Assessment of Study Lenses - Deposits
Description
Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)
Time Frame
15min & 6hrs
Title
Lens Surface Assessment of Study Lenses - Surface Acceptance
Description
Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Time Frame
15min & 6hrs
Title
Subjective Rating For Comfort - Comfort Since Last Visit
Description
Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Time Frame
15min, 3hrs, 6hrs
Title
Subjective Rating For Comfort Preference
Description
Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Time Frame
1min, 15min, 3hrs, 6hrs
Title
Subjective Rating For Handling - Insertion
Description
Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Time Frame
1 min
Title
Subjective Rating For Handling - Removal
Description
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
Time Frame
1 min
Title
Investigator's Assessment of Stability
Description
Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
Time Frame
15min & 6hrs
Title
General Lens Fit - Fit Acceptance
Description
Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Time Frame
15min & 6hrs
Title
Lens Fitting - Rotation/Mislocation
Description
Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Time Frame
Baseline, 15min & 6hrs
Title
Anterior Ocular Health - Corneal Staining (Central)
Description
Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Corneal Staining (Nasal)
Description
Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Corneal Staining (Temporal)
Description
Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - CornealStaining (Superior)
Description
Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Corneal Staining (Inferior)
Description
Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Conjunctival Staining (Nasal)
Description
Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Conjunctival Staining (Superior)
Description
Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Conjunctival Staining (Temporal)
Description
Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Time Frame
baseline & 6hrs
Title
Anterior Ocular Health - Conjunctival Staining (Inferior)
Description
Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Time Frame
baseline & 6hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination
Exclusion Criteria:
Has never worn contact lenses before.
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 (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
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
Pete S Kollbaum, O.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CORL, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
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