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

Not Applicable

Completed

Conditions: Astigmatism
Myopia

Interventions: Device: comfilcon A Toric

Registration Number: NCT02193178

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
comfilcon A toric	comfilcon A Toric	Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	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.
Overall Vision	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.
Lens Fit - Overall Stability	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
Anterior Ocular Health - Palpebral Hyperemia and Roughness	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
Anterior Ocular Health - Conjunctival Staining and Indentation	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
Anterior Ocular Health - Corneal Staining	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
Visual Acuity	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.
Subjective Preference - Comfort	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
Handling	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
Overall Satisfaction	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.
Anterior Ocular Health - Bulbar and Limbal Redness	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
Lens Fit - Rotation	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.
Lens Fit Acceptance	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)
Preference - Vision	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
Preference - Handling	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
Overall Preference	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
Investigator Acceptability	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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Bloomington, Indiana, United States
Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
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Houston, Texas, United States