Trial Outcomes & Findings for Multicenter Dispensing Study of Biofinity Lenses in Extended Range (NCT NCT02060539)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline

Results posted on

2017-12-11

Participant Flow

Study included 2 visits screening and fitting. Up to 50 existing lens wearers prescriptions from +20 to -20D spheres fitted. Participants evaluated at baseline/screening and lens dispensing visit with at least 1 other visit occurring at minium of 2 weeks lens wear.

Participant milestones

Participant milestones
Measure	Comfilcon A Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Age, Continuous	43 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Dryness (During Day and Dryness at Night) Dryness During Day	69 units on a scale Standard Deviation 17
Dryness (During Day and Dryness at Night) Dryness at End of Day	53 units on a scale Standard Deviation 25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Dryness (During Day)	92 units on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Dryness (During Day and Dryness at Night) Dryness	87 units on a scale Standard Deviation 12
Dryness (During Day and Dryness at Night) Dryness at End of Day	76 units on a scale Standard Deviation 24

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Comfort (Insertion, End of Day, Overall) Comfort	86 units on a scale Standard Deviation 8
Comfort (Insertion, End of Day, Overall) Comfort at End of Day	62 units on a scale Standard Deviation 18
Comfort (Insertion, End of Day, Overall) Overall Comfort	83 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Comfort (Insertion)	89 units on a scale Standard Deviation 9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Comfort (Insertion, End of Day, Overall) Comfort	89 units on a scale Standard Deviation 11
Comfort (Insertion, End of Day, Overall) Comfort at End of Day	76 units on a scale Standard Deviation 22
Comfort (Insertion, End of Day, Overall) Overall Comfort	86 units on a scale Standard Deviation 17

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Ghosting (Multiple Images)	90 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Ghosting (Multiple Images)	93 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Ghosting (Multiple Images)	92 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Hazing (Blurred Edges)	79 units on a scale Standard Deviation 24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Hazing (Blurred Edges)	92 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Vision Quality (During Day and at Night) Vision During the Day	78 units on a scale Standard Deviation 17
Vision Quality (During Day and at Night) Vision at Night	62 units on a scale Standard Deviation 22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Vision Quality (During Day)	87 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Vision Quality (During Day and at Night) Vision During the Day	86 units on a scale Standard Deviation 16
Vision Quality (During Day and at Night) Vision at Night	78 units on a scale Standard Deviation 22

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Handling (Insertion, Removal, Overall) Ease of Insertion	93 units on a scale Standard Deviation 10
Handling (Insertion, Removal, Overall) Ease of Removal	87 units on a scale Standard Deviation 13
Handling (Insertion, Removal, Overall) Ease of Handling Overall	91 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Handling (Insertion, Removal, Overall) Ease of Insertion	94 units on a scale Standard Deviation 7
Handling (Insertion, Removal, Overall) Ease of Removal	83 units on a scale Standard Deviation 19
Handling (Insertion, Removal, Overall) Ease of Handling Overall	89 units on a scale Standard Deviation 13

PRIMARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Satisfaction of Comfort, Vision, Handling	90 units on a scale Standard Deviation 8

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Satisfaction of Comfort, Vision, Handling	82 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Satisfaction of Comfort, Vision, Handling	87 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Comfort Preference comfilcon A lenses	47 percentage of participants
Comfort Preference habitual lenses	16 percentage of participants
Comfort Preference no preference	37 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Comfort Preference comfilcon A lenses	42 percentage of participants
Comfort Preference habitual lenses	26 percentage of participants
Comfort Preference no preference	32 percentage of participants

PRIMARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Vision Preference comfilcon A lenses	42 percentage of participants
Vision Preference habitual lenses	0 percentage of participants
Vision Preference no preference	58 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Vision Preference comfilcon A lenses	53 percentage of participants
Vision Preference habitual lenses	31 percentage of participants
Vision Preference no preference	16 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Handling Preference comfilcon A lenses	32 percentage of participants
Handling Preference habitual lenses	32 percentage of participants
Handling Preference no preference	37 percentage of participants

PRIMARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Preference comfilcon A lenses	37 percentage of participants
Overall Preference habitual lenses	5 percentage of participants
Overall Preference no preference	58 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Preference comfilcon A lenses	63 percentage of participants
Overall Preference habitual lenses	21 percentage of participants
Overall Preference no preference	16 percentage of participants

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Centration - Habitual Lenses optimum	53 percentage of lenses
Lens Centration - Habitual Lenses slightly decentered	37 percentage of lenses
Lens Centration - Habitual Lenses extremely decentered	11 percentage of lenses

SECONDARY outcome

Timeframe: Dispense

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Centration optimum	63 percentage of lenses
Lens Centration slightly decentered	26 percentage of lenses
Lens Centration extremely decentered	10 percentage of lenses

SECONDARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Centration optimum	63 percentage of lenses
Lens Centration slightly decentered	32 percentage of lenses
Lens Centration extremely decentered	5 percentage of lenses

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Movement - Habitual Lenses	2.47 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Dispense

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Movement	2.39 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Lens Movement	2.45 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Fit Acceptance	3.33 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Dispense

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Fit Acceptance	3.47 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Lenses Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Fit Acceptance	3.45 units on a scale Standard Deviation 0.394

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Visual Acuity VA HC	0.16 logMar Standard Deviation 0.12
Visual Acuity VA LC	0.22 logMar Standard Deviation 0.14
Visual Acuity VA HC (OU)	0.04 logMar Standard Deviation 0.13
Visual Acuity VA LC (OU)	0.15 logMar Standard Deviation 0.15

SECONDARY outcome

Timeframe: Dispense

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Visual Acuity VA HC	0.10 logMar Standard Deviation 0.15
Visual Acuity VA LC	0.18 logMar Standard Deviation 0.16
Visual Acuity VA HC (OU)	0.03 logMar Standard Deviation 0.13
Visual Acuity VA LC (OU)	0.11 logMar Standard Deviation 0.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Visual Acuity VA HC	0.11 logMar Standard Deviation 0.11
Visual Acuity VA LC	0.18 logMar Standard Deviation 0.15
Visual Acuity VA HC (OU)	0.02 logMar Standard Deviation 0.12
Visual Acuity VA LC (OU)	0.11 logMar Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline

Population: Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Eyes Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Anterior Ocular Physiological Response Conjunctival Staining (n=16)	0.31 units on a scale Standard Deviation 0.55
Anterior Ocular Physiological Response Overall Redness Bulbar	1.13 units on a scale Standard Deviation 0.64
Anterior Ocular Physiological Response Overall Redness Limbal	0.84 units on a scale Standard Deviation 0.78
Anterior Ocular Physiological Response Overall Corneal Staining Type	0.68 units on a scale Standard Deviation 0.53
Anterior Ocular Physiological Response Corneal Staining Extent (n=19)	0.66 units on a scale Standard Deviation 0.58
Anterior Ocular Physiological Response Overall Palpebral Injection	0.8 units on a scale Standard Deviation 0.69
Anterior Ocular Physiological Response Overall Palpebral Papillae (n=8)	0.3 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: 2 Weeks

Population: Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=38 Eyes Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Anterior Ocular Physiological Response Overall Redness Bulbar	1.00 units on a scale Standard Deviation 0.69
Anterior Ocular Physiological Response Overall Redness Limbal	0.74 units on a scale Standard Deviation 0.81
Anterior Ocular Physiological Response Overall Corneal Staining Type	0.47 units on a scale Standard Deviation 0.61
Anterior Ocular Physiological Response Corneal Staining Extent (n=19)	0.45 units on a scale Standard Deviation 0.60
Anterior Ocular Physiological Response Conjunctival Staining (n=16)	0.94 units on a scale Standard Deviation 0.96
Anterior Ocular Physiological Response Overall Palpebral Injection	0.9 units on a scale Standard Deviation 0.61
Anterior Ocular Physiological Response Overall Palpebral Papillae (n=8)	0.7 units on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Average Wearing Time	13 hours Standard Deviation 3.6

SECONDARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Outcome measures
Measure	Comfilcon A n=19 Participants Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Average Wearing Time	12.5 hours Standard Deviation 2.8

Adverse Events

Comfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cheryl McKinnon

CooperVision

Phone: 925-251-2034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information gathered during this study is proprietary and should be made available only to those directly involved in the study. Information and reports arising from this project are the property of the sponsor.
Publication restrictions are in place

Restriction type: OTHER