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OpenTrials
Completed

NCT Number: NCT02185105

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

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CORL, Indiana University

Bloomington, Indiana, 47405, United States

About this study

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

comfilcon A MTO

Device

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Other names: Biofinity Toric MTO

comfilcon A

Device

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Other names: Biofinity Toric

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2014
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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