Multicenter Dispensing Study of Biofinity Lenses in Extended Range

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02060539
• Collaborator: (none)
• Enrollment: 19
• Locations: 4
• Arm: 1
• Duration (Months): 14
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: Biofinity XR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Dispensing Study of Biofinity Lenses in Extended Range
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biofinity XR Participants dispensed Biofinity XR lenses over two weeks of lens wear	Device: Biofinity XR

Outcome Measures

Primary Outcome Measures

1. Dryness (During Day and Dryness at Night) [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.

2. 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.

3. 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.

4. Comfort (Insertion, End of Day, Overall) [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.

5. 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.

6. 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.

7. Ghosting (Multiple Images) [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.

8. Ghosting (Multiple Images) [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.

9. 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.

10. Hazing (Blurred Edges) [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.

11. 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.

12. Vision Quality (During Day and at Night) [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.

13. 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.

14. 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.

15. Handling (Insertion, Removal, Overall) [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.

16. 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.

17. Overall Satisfaction of Comfort, Vision, Handling [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.

18. Overall Satisfaction of Comfort, Vision, Handling [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.

19. 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.

20. Comfort Preference [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.

21. 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.

22. Vision Preference [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.

23. 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.

24. 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.

25. Overall Preference [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.

26. 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.

Secondary Outcome Measures

1. Lens Centration - Habitual Lenses [Baseline]

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

2. Lens Centration [Dispense]

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

3. Lens Centration [2 Weeks]

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

4. 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.

5. Lens Movement [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.

6. 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.

7. Overall Fit Acceptance [Baseline]

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

8. Overall Fit Acceptance [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.

9. 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.

10. Visual Acuity [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.

11. Visual Acuity [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.

12. 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.

13. Anterior Ocular Physiological Response [Baseline]

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

14. 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.

15. Average Wearing Time [Baseline]

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

16. Average Wearing Time [2 Weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Berkeley Clinica Research Center	Berkeley	California	United States	94720-2020
2	CORL, Indiana University School of Optometry	Indianapolis	Indiana	United States	46266-6057
3	TERTC, University of Houston	Houston	Texas	United States	77204-2020
4	CCLR, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, CCLR, University of Waterloo
• Principal Investigator: Meng Lin, CRC, University of California Berkeley
• Principal Investigator: Jan Bergmanson, TERTC, University of Houston
• Principal Investigator: Pete Kollbaum, CORL, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02060539
• Other Study ID Numbers: CV-13-47
• First Posted: Feb 12, 2014
• Last Update Posted: Dec 11, 2017
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Period Title: Overall Study
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (17)
Sex: Female, Male (Count of Participants)
Female	10 52.6%
Male	9 47.4%
Region of Enrollment (participants) [Number]
Canada	4 21.1%
United States	15 78.9%

Outcome Measures

1. Primary Outcome

Title	Dryness (During Day and Dryness at Night)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Dryness During Day	69 (17)
Dryness at End of Day	53 (25)

2. Secondary Outcome

Title	Lens Centration - Habitual Lenses
Description	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
optimum	53
slightly decentered	37
extremely decentered	11

3. Primary Outcome

Title	Dryness (During Day)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	92 (10)

4. Primary Outcome

Title	Dryness (During Day and Dryness at Night)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Dryness	87 (12)
Dryness at End of Day	76 (24)

5. Primary Outcome

Title	Comfort (Insertion, End of Day, Overall)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Comfort	86 (8)
Comfort at End of Day	62 (18)
Overall Comfort	83 (15)

6. Primary Outcome

Title	Comfort (Insertion)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	89 (9)

7. Primary Outcome

Title	Comfort (Insertion, End of Day, Overall)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Comfort	89 (11)
Comfort at End of Day	76 (22)
Overall Comfort	86 (17)

8. Primary Outcome

Title	Ghosting (Multiple Images)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	90 (12)

9. Primary Outcome

Title	Ghosting (Multiple Images)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	93 (15)

10. Primary Outcome

Title	Ghosting (Multiple Images)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	92 (15)

11. Primary Outcome

Title	Hazing (Blurred Edges)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	79 (24)

12. Primary Outcome

Title	Hazing (Blurred Edges)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	92 (14)

13. Primary Outcome

Title	Vision Quality (During Day and at Night)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Vision During the Day	78 (17)
Vision at Night	62 (22)

14. Primary Outcome

Title	Vision Quality (During Day)
Description	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.
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	87 (15)

15. Primary Outcome

Title	Vision Quality (During Day and at Night)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Vision During the Day	86 (16)
Vision at Night	78 (22)

16. Primary Outcome

Title	Handling (Insertion, Removal, Overall)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Ease of Insertion	93 (10)
Ease of Removal	87 (13)
Ease of Handling Overall	91 (12)

17. Primary Outcome

Title	Handling (Insertion, Removal, Overall)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Ease of Insertion	94 (7)
Ease of Removal	83 (19)
Ease of Handling Overall	89 (13)

18. Primary Outcome

Title	Overall Satisfaction of Comfort, Vision, Handling
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	90 (8)

19. Primary Outcome

Title	Overall Satisfaction of Comfort, Vision, Handling
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	82 (15)

20. Primary Outcome

Title	Overall Satisfaction of Comfort, Vision, Handling
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [units on a scale]	87 (15)

21. Primary Outcome

Title	Comfort Preference
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	47 247.4%
habitual lenses	16 84.2%
no preference	37 194.7%

22. Primary Outcome

Title	Comfort Preference
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	42 221.1%
habitual lenses	26 136.8%
no preference	32 168.4%

23. Primary Outcome

Title	Vision Preference
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	42 221.1%
habitual lenses	0 0%
no preference	58 305.3%

24. Primary Outcome

Title	Vision Preference
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	53 278.9%
habitual lenses	31 163.2%
no preference	16 84.2%

25. Primary Outcome

Title	Handling Preference
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	32 168.4%
habitual lenses	32 168.4%
no preference	37 194.7%

26. Primary Outcome

Title	Overall Preference
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	37 194.7%
habitual lenses	5 26.3%
no preference	58 305.3%

27. Primary Outcome

Title	Overall Preference
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
comfilcon A lenses	63 331.6%
habitual lenses	21 110.5%
no preference	16 84.2%

28. Secondary Outcome

Title	Lens Centration
Description	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
optimum	63
slightly decentered	26
extremely decentered	10

29. Secondary Outcome

Title	Lens Centration
Description	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
optimum	63
slightly decentered	32
extremely decentered	5

30. Secondary Outcome

Title	Lens Movement - Habitual Lenses
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	2.47 (0.92)

31. Secondary Outcome

Title	Lens Movement
Description	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.
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	2.39 (0.52)

32. Secondary Outcome

Title	Lens Movement
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	2.45 (0.60)

33. Secondary Outcome

Title	Overall Fit Acceptance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	3.33 (0.59)

34. Secondary Outcome

Title	Overall Fit Acceptance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	3.47 (0.51)

35. Secondary Outcome

Title	Overall Fit Acceptance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Lenses	38
Mean (Standard Deviation) [units on a scale]	3.45 (0.394)

36. Secondary Outcome

Title	Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
VA HC	0.16 (0.12)
VA LC	0.22 (0.14)
VA HC (OU)	0.04 (0.13)
VA LC (OU)	0.15 (0.15)

37. Secondary Outcome

Title	Visual Acuity
Description	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.
Time Frame	Dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
VA HC	0.10 (0.15)
VA LC	0.18 (0.16)
VA HC (OU)	0.03 (0.13)
VA LC (OU)	0.11 (0.14)

38. Secondary Outcome

Title	Visual Acuity
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
VA HC	0.11 (0.11)
VA LC	0.18 (0.15)
VA HC (OU)	0.02 (0.12)
VA LC (OU)	0.11 (0.14)

39. Secondary Outcome

Title	Anterior Ocular Physiological Response
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Eyes	38
Overall Redness Bulbar	1.13 (0.64)
Overall Redness Limbal	0.84 (0.78)
Overall Corneal Staining Type	0.68 (0.53)
Corneal Staining Extent (n=19)	0.66 (0.58)
Conjunctival Staining (n=16)	0.31 (0.55)
Overall Palpebral Injection	0.8 (0.69)
Overall Palpebral Papillae (n=8)	0.3 (0.51)

40. Secondary Outcome

Title	Anterior Ocular Physiological Response
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Measure Eyes	38
Overall Redness Bulbar	1.00 (0.69)
Overall Redness Limbal	0.74 (0.81)
Overall Corneal Staining Type	0.47 (0.61)
Corneal Staining Extent (n=19)	0.45 (0.60)
Conjunctival Staining (n=16)	0.94 (0.96)
Overall Palpebral Injection	0.9 (0.61)
Overall Palpebral Papillae (n=8)	0.7 (0.65)

41. Secondary Outcome

Title	Average Wearing Time
Description	Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [hours]	13 (3.6)

42. Secondary Outcome

Title	Average Wearing Time
Description	Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
Measure Participants	19
Mean (Standard Deviation) [hours]	12.5 (2.8)

Adverse Events

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A
All Cause Mortality
	Comfilcon A
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Comfilcon A
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.