Skip to main content
OpenTrials
Completed

NCT Number: NCT02193178

Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Completed

Looking for future studies?

Notify Me

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

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University, Bloomington, Indiana, United States

Loading trial locations.

About this study

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has had an 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 20/50 or better (in at least one eye)
  • Currently wears soft toric contact lenses in both eyes
  • Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
  • -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
  • +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
  • -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
  • -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
  • +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses

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 abnormality that would affect the wearing of contact lenses;
  • Has undergone corneal refractive surgery;
  • Is participating in any other type of eye related clinical or research study.

Treatment and study plan

comfilcon A Toric

Device

Contact lenses

Other names: Biofinity

Primary outcomes

  1. Overall Comfort

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.

  2. Overall Vision

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post

    Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.

  3. Handling

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy

  4. Overall Satisfaction

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.

  5. Lens Fit - Rotation

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.

  6. Lens Fit - Overall Stability

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability

  7. Lens Fit Acceptance

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)

  8. Anterior Ocular Health - Palpebral Hyperemia and Roughness

    Time frame: Baseline and 2 weeks

    Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe

  9. Anterior Ocular Health - Bulbar and Limbal Redness

    Time frame: Baseline and 2 weeks

    Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection

  10. Anterior Ocular Health - Corneal Staining

    Time frame: Baseline and 2 weeks

    Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area

  11. Anterior Ocular Health - Conjunctival Staining and Indentation

    Time frame: Baseline and 2 weeks

    Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe

  12. Visual Acuity

    Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline

    Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.

  13. Subjective Preference - Comfort

    Time frame: Baseline and 2 weeks

    Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  14. Preference - Vision

    Time frame: Baseline and 2 weeks

    Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  15. Preference - Handling

    Time frame: Baseline and 2 weeks

    Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  16. Overall Preference

    Time frame: Baseline and 2 weeks

    Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  17. Investigator Acceptability

    Time frame: Baseline and 2 weeks

    Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2014
Registry last updated
Jul 29, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.