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

Not Applicable

Completed

Conditions: Astigmatism

Interventions: Device: somofilcon A toric contact lens
Device: fanfilcon A toric contact lens

Registration Number: NCT04050605

Lead Sponsor: Coopervision, Inc.

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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
somofilcon A toric (habitual), then fanfilcon toric (test)	fanfilcon A toric contact lens	Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.
somofilcon A toric (habitual), then fanfilcon toric (test)	somofilcon A toric contact lens	Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.

Primary Outcome Measures

Name	Time	Method
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).
Lens Centration - Fanfilcon A Toric Lens	4-weeks	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	4-weeks	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
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).
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).
Corneal Coverage - Fanfilcon A Toric Lens	4-weeks	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
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).
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).

Secondary Outcome Measures

Name	Time	Method
Average Daily Wearing Time - Fanfilcon A Toric Lens	4 weeks	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens	4 weeks	Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Average Comfortable Wearing Time - Fanfilcon A Toric Lens	4 weeks	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
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.