Multicenter Dispensing Study of Biofinity Lenses in Extended Range

N/ACompletedNCT02060539

CooperVision, Inc.19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia Hyperopia

Interventions

Biofinity XRDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) 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. Exclusion Criteria: * 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.

Locations (4)

UC Berkeley Clinica Research Center

Berkeley, California, United States

CORL, Indiana University School of Optometry

Indianapolis, Indiana, United States

TERTC, University of Houston

Houston, Texas, United States

CCLR, University of Waterloo

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Dryness (During Day and Dryness at Night)

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 habitual lens history at baseline.

Time frame: Baseline

Dryness (During Day)

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.

Time frame: Dispense

Dryness (During Day and Dryness at Night)

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.

Time frame: 2 Weeks

Comfort (Insertion, End of Day, Overall)

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 habitual lens history at baseline.

Time frame: Baseline

Comfort (Insertion)

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.

Time frame: Dispense

Comfort (Insertion, End of Day, Overall)

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.

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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Ghosting (Multiple Images)

Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.

Time frame: Baseline

Ghosting (Multiple Images)

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 dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

Time frame: Dispense

Ghosting (Multiple Images)

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.

Time frame: 2 Weeks

Hazing (Blurred Edges)

Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.

Time frame: Baseline

Hazing (Blurred Edges)

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.

Time frame: 2 Weeks

Vision Quality (During Day and at Night)

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 habitual lens history at baseline.

Time frame: Baseline

Vision Quality (During Day)

Time frame: Dispense

Vision Quality (During Day and at Night)

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.

Time frame: 2 Weeks

Handling (Insertion, Removal, Overall)

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 habitual lens history at baseline.

Time frame: Baseline

Handling (Insertion, Removal, Overall)

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.

Time frame: 2 weeks

Overall Satisfaction of Comfort, Vision, Handling

Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

Time frame: Dispense

Overall Satisfaction of Comfort, Vision, Handling

Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.

Time frame: Baseline

Overall Satisfaction of Comfort, Vision, Handling

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.

Time frame: 2 Weeks

Comfort Preference

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 dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

Time frame: Dispense

Comfort Preference

Time frame: 2 Weeks

Vision Preference

Time frame: Dispense

Vision Preference

Time frame: 2 Weeks

Handling Preference

Time frame: 2 Weeks

Overall Preference

Time frame: Dispense

Overall Preference

Time frame: 2 Weeks

Secondary Outcomes

Lens Centration - Habitual Lenses

Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.

Time frame: Baseline

Lens Centration

Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.

Time frame: Dispense

Lens Centration

Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.

Time frame: 2 Weeks

Lens Movement - Habitual Lenses

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.

Time frame: Baseline

Lens Movement

Time frame: Dispense

Lens Movement

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.

Time frame: 2 Weeks

Overall Fit Acceptance

Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.

Time frame: Baseline

Overall Fit Acceptance

Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

Time frame: Dispense

Overall Fit Acceptance

Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.

Time frame: 2 Weeks

Visual Acuity

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 for habitual lenses at baseline.

Time frame: Baseline

Visual Acuity

Time frame: Dispense

Visual Acuity

Time frame: 2 Weeks

Anterior Ocular Physiological Response

Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.

Time frame: Baseline

Anterior Ocular Physiological Response

Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.

Time frame: 2 Weeks

Average Wearing Time

Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.

Time frame: Baseline

Average Wearing Time

Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.

Time frame: 2 Weeks