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Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

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ClinicalTrials.gov Identifier: NCT02185105
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : January 2, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Device: comfilcon A MTO Device: comfilcon A Not Applicable

Detailed Description:
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: comfilcon A
Randomized to a test lens in one eye and control lens in the other as a matched pair.
Other Name: Biofinity Toric
Active Comparator: 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.
 Device: comfilcon A MTO
Randomized to a test lens in one eye and control lens in the other as a matched pair.
Other Name: Biofinity Toric MTO


Outcome Measures
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Primary Outcome Measures :
  1. Lens Surface Assessment of Study Lenses - Surface Wettability [ Time Frame: 15min & 6hrs ]
    Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)

  2. Lens Surface Assessment of Study Lenses - Deposits [ Time Frame: 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)

  3. Lens Surface Assessment of Study Lenses - Surface Acceptance [ Time Frame: 15min & 6hrs ]
    Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)

  4. Subjective Rating For Comfort - Comfort Since Last Visit [ Time Frame: 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)

  5. Subjective Rating For Comfort Preference [ Time Frame: 1min, 15min, 3hrs, 6hrs ]
    Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)

  6. Subjective Rating For Handling - Insertion [ Time Frame: 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)

  7. Subjective Rating For Handling - Removal [ Time Frame: 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)

  8. Investigator's Assessment of Stability [ Time Frame: 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.

  9. General Lens Fit - Fit Acceptance [ Time Frame: 15min & 6hrs ]
    Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)

  10. Lens Fitting - Rotation/Mislocation [ Time Frame: 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=(-).

  11. Anterior Ocular Health - Corneal Staining (Central) [ Time Frame: 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)

  12. Anterior Ocular Health - Corneal Staining (Nasal) [ Time Frame: 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)

  13. Anterior Ocular Health - Corneal Staining (Temporal) [ Time Frame: 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)

  14. Anterior Ocular Health - CornealStaining (Superior) [ Time Frame: 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)

  15. Anterior Ocular Health - Corneal Staining (Inferior) [ Time Frame: 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)

  16. Anterior Ocular Health - Conjunctival Staining (Nasal) [ Time Frame: 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).

  17. Anterior Ocular Health - Conjunctival Staining (Superior) [ Time Frame: 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).

  18. Anterior Ocular Health - Conjunctival Staining (Temporal) [ Time Frame: 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).

  19. Anterior Ocular Health - Conjunctival Staining (Inferior) [ Time Frame: 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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.
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): NCT02185105


Locations
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United States, Indiana
CORL, Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Pete S Kollbaum, O.D. Indiana University
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02185105    
Other Study ID Numbers: CV-14-04
First Posted: July 9, 2014    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: March 7, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases