Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04050605
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: somofilcon A toric contact lens; Device: fanfilcon A toric contact lens	N/A

Detailed Description

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
• 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 preservative free sterile saline just prior to dispensing to maintain subject masking of the study lenses.
• Primary Purpose: Other
• Official Title: Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
• Actual Study Start Date: Jun 4, 2019
• Actual Primary Completion Date: Aug 16, 2019
• Actual Study Completion Date: Oct 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A toric (habitual), then fanfilcon toric (test) Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.	Device: somofilcon A toric contact lens; Contact Lens; Other Names: Habitual lens ; Device: fanfilcon A toric contact lens; Contact Lens; Other Names: Test Lens

Outcome Measures

Primary Outcome Measures

1. Lens Centration - Somofilcon A Toric (Habitual) Lens [Baseline]

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

2. Lens Centration - Somofilcon A Toric (Habitual) Lens [4 weeks]

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

3. Lens Centration - Fanfilcon A Toric Lens [Baseline]

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

4. Lens Centration - Fanfilcon A Toric Lens [2-weeks]

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

5. Lens Centration - Fanfilcon A Toric Lens [4-weeks]

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

6. Corneal Coverage - Somofilcon A Toric (Habitual ) Lens [Baseline]

   Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

7. Corneal Coverage - Somofilcon A Toric (Habitual ) Lens [4-weeks]

   Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

8. Corneal Coverage - Fanfilcon A Toric Lens [Baseline]

   Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

9. Corneal Coverage - Fanfilcon A Toric Lens [2-weeks]

   Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

10. Corneal Coverage - Fanfilcon A Toric Lens [4-weeks]

    Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

11. Post-Blink Movement - Somofilcon A Toric (Habitual) Lens [Baseline]

    Post-Blink movement (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 - Somofilcon A Toric (Habitual) Lens [4-weeks]

    Post-Blink movement (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 - Fanfilcon A Toric Lens [Baseline]

    Post-Blink movement (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 - Fanfilcon A Toric Lens [2-weeks]

    Post-Blink movement (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 - Fanfilcon A Toric Lens [4-weeks]

    Post-Blink movement (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. Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens [Baseline]

    Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).

17. Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens [4-weeks]

    Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).

18. Overall Lens Fit Acceptance - Fanfilcon A Toric Lens [Baseline]

    Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).

19. Overall Lens Fit Acceptance - Fanfilcon A Toric Lens [2-weeks]

    Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).

20. Overall Lens Fit Acceptance - Fanfilcon A Toric Lens [4-weeks]

    Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).

Secondary Outcome Measures

1. Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens [4 weeks]

   Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.

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

   Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.

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

   Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.

4. Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens [4 weeks]

   Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day

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

   Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.

6. Average Comfortable Wearing Time - Fanfilcon A Toric Lens [4 weeks]

   Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.

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 toric 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 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 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 Velázquez Guerrero, MSc., FIACLE, School of Optometry, National Autonomous University (UNAM), Mexico City

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 4, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04050605
• Other Study ID Numbers: EX-MKTG-102
• First Posted: Aug 8, 2019
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 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: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)
Arm/Group Description	Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)
Arm/Group Description	Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.1 (6.8)
Sex: Female, Male (Count of Participants)
Female	27 67.5%
Male	13 32.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Mexico	40 100%

Outcome Measures

1. Primary Outcome

Title	Lens Centration - Somofilcon A Toric (Habitual) Lens
Description	Lens Centration assessed using 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	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Optimum	100
Acceptable	0
Unacceptable	0

2. Primary Outcome

Title	Lens Centration - Somofilcon A Toric (Habitual) Lens
Description	Lens Centration (using 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	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Optimum	100
Acceptable	0
Unacceptable	0

3. Primary Outcome

Title	Lens Centration - Fanfilcon A Toric Lens
Description	Lens Centration using 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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Optimum	100
Acceptable	0
Unacceptable	0

4. Primary Outcome

Title	Lens Centration - Fanfilcon A Toric Lens
Description	Lens Centration using 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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Optimum	100
Acceptable	0
Unacceptable	0

5. Primary Outcome

Title	Lens Centration - Fanfilcon A Toric Lens
Description	Lens Centration using 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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Optimum	100
Acceptable	0
Unacceptable	0

6. Primary Outcome

Title	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Description	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Yes	100
No	0

7. Primary Outcome

Title	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Description	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks.. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Yes	100
No	0

8. Primary Outcome

Title	Corneal Coverage - Fanfilcon A Toric Lens
Description	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Yes	100
No	0

9. Primary Outcome

Title	Corneal Coverage - Fanfilcon A Toric Lens
Description	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Yes	100
No	0

10. Primary Outcome

Title	Corneal Coverage - Fanfilcon A Toric Lens
Description	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Yes	100
No	0

11. Primary Outcome

Title	Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Description	Post-Blink movement (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	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

12. Primary Outcome

Title	Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Description	Post-Blink movement (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	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4 weeks. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

13. Primary Outcome

Title	Post-Blink Movement - Fanfilcon A Toric Lens
Description	Post-Blink movement (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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

14. Primary Outcome

Title	Post-Blink Movement - Fanfilcon A Toric Lens
Description	Post-Blink movement (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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

15. Primary Outcome

Title	Post-Blink Movement - Fanfilcon A Toric Lens
Description	Post-Blink movement (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 Toric Lens
Arm/Group Description	Participants were refitted with fanfilcon A toric lens. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	2.0 (0.0)

16. Primary Outcome

Title	Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Description	Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks.. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	3.8 (0.5)

17. Primary Outcome

Title	Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Description	Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks.. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	3.8 (0.5)

18. Primary Outcome

Title	Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description	Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	fanfilconA Toric
Arm/Group Description	Participants were their refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	3.9 (0.3)

19. Primary Outcome

Title	Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description	Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	fanfilconA Toric
Arm/Group Description	Participants were their refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

20. Primary Outcome

Title	Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description	Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	fanfilconA Toric
Arm/Group Description	Participants were their refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [units on a scale]	4.0 (0.2)

21. Secondary Outcome

Title	Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens
Description	Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks.. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	10.4 (3.0)

22. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Toric Lens
Description	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric
Arm/Group Description	Participants were refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	10.5 (2.7)

23. Secondary Outcome

Title	Average Daily Wearing Time - Fanfilcon A Toric Lens
Description	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric
Arm/Group Description	Participants were refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	10.9 (2.6)

24. Secondary Outcome

Title	Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens
Description	Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Toric (Habitual)
Arm/Group Description	Participants wore their habitual somofilcon A toric lens for 4-weeks.. somofilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	8.4 (3.5)

25. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Description	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric
Arm/Group Description	Participants were refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	9.0 (2.6)

26. Secondary Outcome

Title	Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Description	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A Toric
Arm/Group Description	Participants were refitted with fanfilcon A toric lens for 4-weeks.. fanfilcon A toric contact lens: Contact Lens
Measure Participants	40
Mean (Standard Deviation) [hours/day]	9.6 (2.6)

Adverse Events

Time Frame	From dispense up to 4-weeks for each lens type, a total of 8-weeks.
Arm/Group Title	Somofilcon A Toric (Habitual) Lens		Fanfilcon A Toric Contact Lens
Arm/Group Description	Participants are habitual wearers of somofilcon A toric lens for 4-weeks somofilcon A toric contact lens: Contact Lens		Participants were refitted with fanfilcon A toric lens for 4-weeks fanfilcon A toric contact lens: Contact Lens
All Cause Mortality
	Somofilcon A Toric (Habitual) Lens		Fanfilcon A Toric Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	Somofilcon A Toric (Habitual) Lens		Fanfilcon A Toric Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A Toric (Habitual) Lens		Fanfilcon A Toric Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (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.