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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: comfilcon A Toric

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
  • Texas
    • Houston, Texas, United States, 77204
      • Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Biofinity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	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 weeks prior to baseline, Baseline, 2 weeks post baseline
Overall Vision	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.	2 weeks prior to baseline, Baseline, 2 weeks post
Handling	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	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Overall Satisfaction	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.	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit - Rotation	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.	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit - Overall Stability	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	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit Acceptance	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)	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Anterior Ocular Health - Palpebral Hyperemia and Roughness	Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe	Baseline and 2 weeks
Anterior Ocular Health - Bulbar and Limbal Redness	Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection	Baseline and 2 weeks
Anterior Ocular Health - Corneal Staining	Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area	Baseline and 2 weeks
Anterior Ocular Health - Conjunctival Staining and Indentation	Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe	Baseline and 2 weeks
Visual Acuity	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.	2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective Preference - Comfort	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	Baseline and 2 weeks
Preference - Vision	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	Baseline and 2 weeks
Preference - Handling	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	Baseline and 2 weeks
Overall Preference	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	Baseline and 2 weeks
Investigator Acceptability	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.	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CV-14-05