Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Overall Comfort
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
comfilcon A toric
Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Intervention: comfilcon A Toric (Device)
Outcomes
Primary Outcomes
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.
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.
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
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
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
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
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.
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
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
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.
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
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.
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)
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
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
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
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.
Secondary Outcomes
No secondary outcomes reported