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

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ClinicalTrials.gov Identifier: NCT02193178
Recruitment Status : Completed
First Posted : July 17, 2014
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: comfilcon A toric
Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Device: comfilcon A Toric
Contact lenses
Other Name: Biofinity




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.

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): NCT02193178


Locations
United States, Indiana
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States, 47405
United States, Texas
Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Jan Bergmanson, OD PhD Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
Principal Investigator: Pete Kollbaum, OD PhD Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02193178     History of Changes
Other Study ID Numbers: CV-14-05
First Posted: July 17, 2014    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases