Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
- Conditions
- MyopiaAstigmatism
- Interventions
- Device: comfilcon A MTODevice: comfilcon A
- Registration Number
- NCT02185105
- Lead Sponsor
- Coopervision, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description comfilcon A comfilcon A MTO Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. comfilcon A MTO comfilcon A Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
- Primary Outcome Measures
Name Time Method Subjective Rating For Handling - Insertion 1 min 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 1 min 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)
General Lens Fit - Fit Acceptance 15min & 6hrs Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Anterior Ocular Health - Corneal Staining (Central) baseline & 6hrs 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)
Lens Surface Assessment of Study Lenses - Surface Wettability 15min & 6hrs 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 15min & 6hrs 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)
Investigator's Assessment of Stability 15min & 6hrs Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
Lens Fitting - Rotation/Mislocation Baseline, 15min & 6hrs 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=(-).
Lens Surface Assessment of Study Lenses - Surface Acceptance 15min & 6hrs 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 15min, 3hrs, 6hrs 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)
Anterior Ocular Health - Corneal Staining (Nasal) baseline & 6hrs 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) baseline & 6hrs 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)
Subjective Rating For Comfort Preference 1min, 15min, 3hrs, 6hrs Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Anterior Ocular Health - CornealStaining (Superior) baseline & 6hrs 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 - Conjunctival Staining (Inferior) baseline & 6hrs 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).
Anterior Ocular Health - Corneal Staining (Inferior) baseline & 6hrs 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) baseline & 6hrs 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) baseline & 6hrs 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) baseline & 6hrs 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CORL, Indiana University
🇺🇸Bloomington, Indiana, United States