Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03835221
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 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 Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
• 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: methafilcon A toric / fanfilcon A toric contact lenses All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.	Device: methafilcon A toric contact lenses; Bilateral daily wear of methafilcon A toric contact lenses; Device: fanfilcon A toric contact lenses; Bilateral daily wear of fanfilcon A toric contact lenses

Outcome Measures

Primary Outcome Measures

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

   Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

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

   Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

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

   Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

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

   Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

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

   Lens centration was assessed on a 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 Toric Contact Lenses [Baseline]

   Corneal coverage was 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 Toric Contact Lenses [4 weeks]

   Corneal coverage was 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 Toric Contact Lenses [Baseline]

   Corneal coverage was 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 Toric Contact Lenses [2 weeks]

   Corneal coverage was 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 Toric Contact Lenses [4 weeks]

    Corneal coverage was 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 Toric Contact Lenses [Baseline]

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses [4 weeks]

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses [Baseline]

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses [2 weeks]

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses [4 weeks]

    Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

16. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses [Baseline]

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

17. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses [4 weeks]

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

18. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [Baseline]

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

19. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [2 weeks]

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

20. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [4 weeks]

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

21. Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses [Baseline]

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

22. Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses [4 weeks]

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

23. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [Baseline]

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

24. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [2 weeks]

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

25. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [4 weeks]

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

26. Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses [Baseline]

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

27. Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses [4 weeks]

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

28. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [Baseline]

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

29. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [2 weeks]

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

30. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses [4 weeks]

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

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

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

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

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

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

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

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

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

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

    Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses [4 weeks]

   Average daily wearing time response by the subject

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

   Average daily wearing time response by the subject

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

   Average daily wearing time response by the subject

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

   Average comfortable wearing time - response by the subject

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

   Average comfortable wearing time - response by the subject

6. Average Comfortable Wearing Time - Fanfilcon A Toric 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 +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 D 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 less than -0.75D or more than -2.50 D of cylinder 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

• 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 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 21, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03835221
• Other Study ID Numbers: EX-MKTG-96
• 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

Arm/Group Title	Methafilcon A / Fanfilcon A Contact Lenses
Arm/Group Description	All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A 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: Methafilcon A
STARTED	43
COMPLETED	42
NOT COMPLETED	1
Period Title: Methafilcon A
STARTED	42
COMPLETED	42
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	43
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	43 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.2 (6.9)
Sex: Female, Male (Count of Participants)
Female	26 60.5%
Male	17 39.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Mexico	43 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Lens centration was assessed on a 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	Methafilcon A
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	43
Optimal Centration	40 93%
Decentration acceptable	3 7%
Decentration unacceptable	0 0%

2. Primary Outcome

Title	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Lens centration was assessed on a 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	Methafilcon A
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	42
Optimal centration	41 95.3%
Decentration acceptable	1 2.3%
Decentration unacceptable	0 0%

3. Primary Outcome

Title	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens centration was assessed on a 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Optimal centration	42 97.7%
Decentration acceptable	0 0%
Decentration unacceptable	0 0%

4. Primary Outcome

Title	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens centration was assessed on a 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Optimal centration	42 97.7%
Decentration acceptable	0 0%
Decentration unacceptable	0 0%

5. Primary Outcome

Title	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens centration was assessed on a 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Optimal centration	42 97.7%
Decentration acceptable	0 0%
Decentration unacceptable	0 0%

6. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Corneal coverage was 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	Methafilcon A
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	43
Yes	100 232.6%
No	0 0%

7. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Corneal coverage was 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	Methafilcon A
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	42
Yes	100 232.6%
No	0 0%

8. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Corneal coverage was 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Yes	100 232.6%
No	0 0%

9. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Corneal coverage was 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Yes	100 232.6%
No	0 0%

10. Primary Outcome

Title	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Corneal coverage was 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Yes	100 232.6%
No	0 0%

11. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Post-blink movement was assessed on a 0-4 scale (where: 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	Methafilcon A
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	43
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

12. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Post-blink movement was assessed on a 0-4 scale (where: 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	Methafilcon A
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	42
Mean (Standard Deviation) [units on a scale]	1.97 (0.15)

13. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Post-blink movement was assessed on a 0-4 scale (where: 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

14. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Post-blink movement was assessed on a 0-4 scale (where: 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	1.97 (0.15)

15. Primary Outcome

Title	Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Post-blink movement was assessed on a 0-4 scale (where: 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	1.97 (0.15)

16. Primary Outcome

Title	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Description	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	43
Mean (Standard Deviation) [Degrees]	2.21 (4.0)

17. Primary Outcome

Title	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Description	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	42
Mean (Standard Deviation) [Degrees]	1.55 (3.2)

18. Primary Outcome

Title	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.71 (1.8)

19. Primary Outcome

Title	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.71 (1.8)

20. Primary Outcome

Title	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.47 (1.9)

21. Primary Outcome

Title	Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	43
Mean (Standard Deviation) [Degrees]	2.79 (4.8)

22. Primary Outcome

Title	Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	42
Mean (Standard Deviation) [Degrees]	2.02 (3.5)

23. Primary Outcome

Title	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.83 (2.2)

24. Primary Outcome

Title	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.95 (2.3)

25. Primary Outcome

Title	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [Degrees]	0.48 (1.5)

26. Primary Outcome

Title	Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	43
Mean (Standard Deviation) [units on a scale]	3.8 (0.4)

27. Primary Outcome

Title	Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methafilcon A
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	42
Mean (Standard Deviation) [units on a scale]	3.8 (0.4)

28. Primary Outcome

Title	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

29. Primary Outcome

Title	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

30. Primary Outcome

Title	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

31. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Description	Overall lens fit acceptance assessed using grade (0-4) 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	Methafilcon A
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	43
Mean (Standard Deviation) [units on a scale]	3.8 (0.4)

32. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Description	Overall lens fit acceptance assessed using grade (0-4) 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	Methafilcon A
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	42
Mean (Standard Deviation) [units on a scale]	3.8 (0.4)

33. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens fit acceptance assessed using grade (0-4) 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

34. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens fit acceptance assessed using grade (0-4) 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

35. Primary Outcome

Title	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description	Overall lens fit acceptance assessed using grade (0-4) 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

36. Secondary Outcome

Title	Average Daily Wearing Time - Methafilcon A Toric 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	Methafilcon A
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	42
Mean (Standard Deviation) [hours / day]	10.4 (2.8)

37. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Toric 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [hours/day]	10.6 (2.8)

38. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Toric 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [hours/day]	11.0 (2.8)

39. Secondary Outcome

Title	Average Comfortable Wearing Time - Methafilcon A Toric 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	Methafilcon A
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	42
Mean (Standard Deviation) [hours/day]	7.6 (2.8)

40. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Toric 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [hours/day]	8.1 (2.9)

41. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Toric 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
Arm/Group Description	All subjects will wear fanfilcon A contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Measure Participants	42
Mean (Standard Deviation) [hours/day]	8.6 (3.1)

Adverse Events

Time Frame	From baseline up to 8 weeks
Arm/Group Title	Methafilcon A Toric Contact Lenses		Fanfilcon A Toric Contact Lenses
Arm/Group Description	All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A toric contact lenses: Bilateral daily wear of methafilcon A toric contact lenses		All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A toric contact lenses: Bilateral daily wear of fanfilcon A toric contact lenses
All Cause Mortality
	Methafilcon A Toric Contact Lenses		Fanfilcon A Toric Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)
Serious Adverse Events
	Methafilcon A Toric Contact Lenses		Fanfilcon A Toric Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Methafilcon A Toric Contact Lenses		Fanfilcon A Toric Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (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.