Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03835078
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: methafilcon A contact lenses; Device: fanfilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
• Primary Purpose: Other
• Official Title: Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Mar 27, 2019
• Actual Study Completion Date: Jul 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: methalfilcon A contact lenses / fanfilcon A contact lenses All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.	Device: methafilcon A contact lenses; Bilateral daily wear of methafilcon A contact lenses; Device: fanfilcon A contact lenses; Bilateral daily wear of fanfilcon A contact lenses

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses [Baseline]

   Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

2. Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses [4 weeks]

   Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

3. Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses [Baseline]

   Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

4. Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses [2 weeks]

   Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

5. Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses [4 weeks]

   Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

6. Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses [Baseline]

   Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

7. Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses [4 weeks]

   Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

8. Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses [Baseline]

   Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

9. Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses [2 weeks]

   Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

10. Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses [4 weeks]

    Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

11. Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses [Baseline]

    Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

12. Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses [4 weeks]

    Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

13. Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses [Baseline]

    Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

14. Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses [2 weeks]

    Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

15. Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses [4 weeks]

    Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

16. Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses [Baseline]

    Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

17. Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses [4 weeks]

    Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

18. Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses [Baseline]

    Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

19. Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses [2 weeks]

    Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

20. Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses [4 weeks]

    Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

21. Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses [Baseline]

    Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

22. Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses [4 weeks]

    Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

23. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses [Baseline]

    Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

24. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses [2 weeks]

    Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

25. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses [4 weeks]

    Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Secondary Outcome Measures

1. Average Daily Wearing Time - Methafilcon A Contact Lenses [4 weeks]

   Average daily wearing time response by the subject

2. Average Daily Wearing Time - Fanfilcon A Contact Lenses [2 weeks]

   Average daily wearing time response by the subject.

3. Average Daily Wearing Time - Fanfilcon A Contact Lenses [4 weeks]

   Average daily wearing time response by the subject

4. Average Comfortable Wearing Time - Methafilcon A Contact Lenses [4 weeks]

   Average comfortable wearing time - response by the subject

5. Average Comfortable Wearing Time - Fanfilcon A Contact Lenses [2 weeks]

   Average comfortable wearing time - response by the subject

6. Average Comfortable Wearing Time - Fanfilcon A Contact Lenses [4 weeks]

   Average comfortable wearing time - response by the subject

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 soft contact lens wearer

• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)

• Have no less than -0.75D (Diopter) of astigmatism in both eyes

• 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:

• Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses

• Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye

• Has a history of not achieving comfortable Contact Lens (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Clinic, National Autonomous University	Mexico City		Mexico

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Ruben Velazquez, MSc FIACLE, School of Optometry, National Autonomous University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 10, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03835078
• Other Study ID Numbers: EX-MKTG-98
• First Posted: Feb 8, 2019
• Last Update Posted: Jun 11, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.

Arm/Group Title	Methalfilcon A Contact Lenses / Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Period Title: Overall Study
STARTED	39
COMPLETED	39
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	39
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	39 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (6.7)
Sex: Female, Male (Count of Participants)
Female	24 61.5%
Male	15 38.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Mexico	39 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Optimal Centration	100 256.4%
Decentration Acceptable	0 0%
Decentartion Unacceptable	0 0%

2. Primary Outcome

Title	Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Optimal Centration	100 256.4%
Decentration Acceptable	0 0%
Decentration Unacceptable	0 0%

3. Primary Outcome

Title	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Optimal Centration	100 256.4%
Decentration Acceptable	0 0%
Decentration Unacceptable	0 0%

4. Primary Outcome

Title	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Optimal Centration	100 256.4%
Decentration Acceptable	0 0%
Decentration Unacceptable	0 0%

5. Primary Outcome

Title	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Optimal Centration	100 256.4%
Decentartion Acceptable	0 0%
Decentration Unacceptable	0 0%

6. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Yes	97.4 249.7%
No	2.6 6.7%

7. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Yes	100 256.4%
No	0 0%

8. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Yes	100 256.4%
No	0 0%

9. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Yes	100 256.4%
No	0 0%

10. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Yes	100 256.4%
No	0 0%

11. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	1.90 (0.3)

12. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	1.95 (0.3)

13. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	1.97 (0.2)

14. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	1.97 (0.2)

15. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	2.0 (0.2)

16. Primary Outcome

Title	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	53.59 (9.6)

17. Primary Outcome

Title	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Description	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	52.31 (6.5)

18. Primary Outcome

Title	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	50.38 (1.8)

19. Primary Outcome

Title	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	50.64 (3.3)

20. Primary Outcome

Title	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	50.51 (3.2)

21. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Description	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	3.69 (0.6)

22. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Description	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	3.74 (0.5)

23. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	3.97 (0.2)

24. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	3.92 (0.3)

25. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [units on a scale]	3.95 (0.3)

26. Secondary Outcome

Title	Average Daily Wearing Time - Methafilcon A Contact Lenses
Description	Average daily wearing time response by the subject
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	12.1 (4.0)

27. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Contact Lenses
Description	Average daily wearing time response by the subject.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	12.2 (2.6)

28. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Contact Lenses
Description	Average daily wearing time response by the subject
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	12.3 (2.6)

29. Secondary Outcome

Title	Average Comfortable Wearing Time - Methafilcon A Contact Lenses
Description	Average comfortable wearing time - response by the subject
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methalfilcon A Contact Lenses
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	10.0 (3.2)

30. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Description	Average comfortable wearing time - response by the subject
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	9.6 (3.0)

31. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Description	Average comfortable wearing time - response by the subject
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	39
Mean (Standard Deviation) [hours / day]	9.7 (2.9)

Adverse Events

Time Frame	From baseline up to 8 weeks
Arm/Group Title	Methafilcon A		Fanfilcon A
Arm/Group Description	All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses		All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A
All Cause Mortality
	Methafilcon A		Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Serious Adverse Events
	Methafilcon A		Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Methafilcon A		Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.