Multicenter Dispensing Study of Biofinity Lenses in Extended Range
- Conditions
- MyopiaHyperopia
- Interventions
- Device: Biofinity XR
- Registration Number
- NCT02060539
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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) with their habitual vision correction
- Currently wears soft contact lenses
- They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses.
- Has any systemic disease affecting ocular health
- Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- Have any active ocular disease and/or infection that would contraindicate contact lens wear.
- Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- Has worn gas permeable contact lenses within the last month.
- Is aphakic
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical research study
- Female who is currently pregnant or is breast-feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biofinity XR Biofinity XR Participants dispensed Biofinity XR lenses over two weeks of lens wear
- Primary Outcome Measures
Name Time Method Dryness (During Day) Dispense Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Comfort (Insertion, End of Day, Overall) 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Dryness (During Day and Dryness at Night) 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
Vision Quality (During Day) Dispense Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Vision Preference 2 Weeks Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Handling Preference 2 Weeks Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Comfort (Insertion) Dispense Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Hazing (Blurred Edges) 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
Ghosting (Multiple Images) 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
Vision Quality (During Day and at Night) 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
Comfort Preference 2 Weeks Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Overall Preference 2 Weeks Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Handling (Insertion, Removal, Overall) 2 weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Overall Satisfaction of Comfort, Vision, Handling 2 Weeks Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
- Secondary Outcome Measures
Name Time Method Overall Fit Acceptance 2 Weeks Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
Anterior Ocular Physiological Response 2 Weeks Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.
Lens Centration 2 Weeks Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
Lens Movement 2 Weeks Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
Lens Centration - Habitual Lenses Baseline Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Average Wearing Time 2 Weeks Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
Lens Movement - Habitual Lenses Baseline Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
Visual Acuity 2 Weeks Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.
Trial Locations
- Locations (4)
TERTC, University of Houston
🇺🇸Houston, Texas, United States
CCLR, University of Waterloo
🇨🇦Waterloo, Ontario, Canada
UC Berkeley Clinica Research Center
🇺🇸Berkeley, California, United States
CORL, Indiana University School of Optometry
🇺🇸Indianapolis, Indiana, United States