Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02406495
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 40.6

Study Details

Study Description

Brief Summary

Open label, 1-week daily disposable, dispensing study

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: filcon IV 1; Device: ocufilcon D	N/A

Detailed Description

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: filcon IV 1 and ocufilcon D Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.	Device: filcon IV 1; contact lens; Device: ocufilcon D; contact lens

Outcome Measures

Primary Outcome Measures

1. Lens Fit, Centration - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable

2. Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

3. Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement

4. Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

Secondary Outcome Measures

1. Visual Acuity - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).

2. Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).

3. Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).

4. Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).

5. Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).

6. Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D [1 Week]

   Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.

7. Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

8. Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

9. Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

   Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

10. Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

    Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

11. Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D [Baseline and 1 Week]

    Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)

• Has had a self-reported visual exam in the last two years

• Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)

• Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)

• Has a spectacle cylinder up to 0.75D in each eye.

• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter.

• Patient contact lens refraction should fit within the available parameters of the study lenses.

• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).

• Is willing to comply with the visit schedule

Exclusion Criteria:

• Is not a habitual wearer of Avaira sphere lenses

• Has a CL prescription outside the range of the available parameters of the study lenses.

• Has a spectacle cylinder ≥1.00D of cylinder in either eye.

• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

• Presence of clinically significant (grade 2-4) anterior segment abnormalities

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (past or present)

• Seborrheic eczema, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Research Group (GIO) Optics Department, University of Valencia	Valencia		Spain	46100

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Robert Montés-Mico, OD MPhil PhD, Optometry Research Group (GIO) Optics Department, University of Valencia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02406495
• Other Study ID Numbers: EX-MKTG-58
• First Posted: Apr 2, 2015
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.92 (5.43)
Sex: Female, Male (Count of Participants)
Female	31 77.5%
Male	9 22.5%

Outcome Measures

1. Secondary Outcome

Title	Visual Acuity - Filcon IV 1 and Ocufilcon D
Description	Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
OD	0 (0)	0 (0)
OS	0 (0)	0 (0)
Binocular	-0.01 (0.03)	-0.01 (0.04)

2. Secondary Outcome

Title	Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description	Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Comfort on insertion	7.4 (1.1)	8.1 (1.3)
Comfort prior to removal	7.3 (1.4)	8.1 (1.3)
Comfort overall	7.3 (1.3)	8.1 (1.4)

3. Primary Outcome

Title	Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Description	Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1 OD (Oculus Dexter)	Filcon IV 1 OS (Oculus Sinister)	Ocufilcon D OD (Oculus Dexter)	Ocufilcon D OS (Oculus Sinister)
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40	40	40
Optimum	58	70	98	98
Decentration acceptable	43	30	3	3
Decentration unacceptable	0	0	0	0

4. Primary Outcome

Title	Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Description	Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1 OD	Filcon IV 1 OS	Ocufilcon D OD	Ocufilcon D OS
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40	40	40
0=Insufficient, unacceptable movement	0	0	0	0
1=Minimal, but acceptable movement	10	10	0	0
2=Optimal movement	23	18	10	10
3=Moderate, but acceptable movement	65	70	90	90
4=Excessive, unacceptable movement	3	3	0	0

5. Primary Outcome

Title	Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Description	Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
OD	49.1 (5.9)	50.1 (0.79)
OS	48.9 (5.2)	50.0 (1.9)

6. Primary Outcome

Title	Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Description	Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1 OD	Filcon IV 1 OS	Ocufilcon D OD	Ocufilcon D OS
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40	40	40
Should not be worn	0	0	0	0
Borderline but acceptable	0	0	0	0
Min. acceptable	0	0	0	0
Not perfect but OK	38	35	0	0
Perfect	63	65	100	100

7. Secondary Outcome

Title	Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description	Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Dryness during day	7.2 (1.3)	8.0 (1.5)
Dryness prior to removal	7.3 (1.3)	8.0 (1.5)
Overall dryness	7.3 (1.3)	8.1 (1.5)

8. Secondary Outcome

Title	Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description	Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Mean (Standard Deviation) [units on a scale]	7.4 (1.2)	8.2 (1.3)

9. Secondary Outcome

Title	Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description	Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Mean (Standard Deviation) [units on a scale]	7.5 (1.3)	8.2 (1.3)

10. Secondary Outcome

Title	Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Description	Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Comfort	20 50%	80 NaN
Dryness	20 50%	80 NaN
Handling	20 50%	80 NaN
Vision	20 50%	80 NaN
Overall	20 50%	80 NaN

11. Secondary Outcome

Title	Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Description	Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Completely Satisfied	20 50%	60 NaN
Somewhat Satisfied	68 170%	35 NaN
Somewhat Dissatisfied	13 32.5%	5 NaN
Completely Dissatisfied	0 0%	0 NaN

12. Secondary Outcome

Title	Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Description	Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Completely Satisfied	20 50%	60 NaN
Somewhat Satisfied	65 162.5%	35 NaN
Somewhat Dissatisfied	15 37.5%	5 NaN
Completely Dissatisfied	0 0%	0 NaN

13. Secondary Outcome

Title	Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Description	Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Completely Satisfied	23 57.5%	60 NaN
Somewhat Satisfied	65 162.5%	38 NaN
Somewhat Dissatisfied	13 32.5%	3 NaN
Completely Dissatisfied	0 0%	0 NaN

14. Secondary Outcome

Title	Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Description	Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Completely Satisfied	23 57.5%	60 NaN
Somewhat Satisfied	65 162.5%	38 NaN
Somewhat Dissatisfied	13 32.5%	3 NaN
Completely Dissatisfied	0 0%	0 NaN

15. Secondary Outcome

Title	Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Description	Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon IV 1	Ocufilcon D
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
Measure Participants	40	40
Completely Satisfied	20 50%	60 NaN
Somewhat Satisfied	68 170%	35 NaN
Somewhat Dissatisfied	13 32.5%	5 NaN
Completely Dissatisfied	0 0%	0 NaN

Adverse Events

Time Frame	From dispense up to one week for each study lenses
Arm/Group Title	Overall Participants
Arm/Group Description	Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens
All Cause Mortality
	Overall Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.