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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04050605

Enrollment

Registered

2019-08-08

Start date

2019-06-04

Completion date

2019-10-18

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

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).

Interventions

DEVICEsomofilcon A toric contact lens

Contact Lens

DEVICEfanfilcon A toric contact lens

Contact Lens

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

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.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Average Daily Wearing Time - Fanfilcon A Toric Lens	2 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	2 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.

Countries

Mexico

Participant flow

Participants by arm

Arm	Count
Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test) 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	40
Total	40

Baseline characteristics

Characteristic	Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	40 Participants	—
Age, Continuous	25.1 years STANDARD_DEVIATION 6.8	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Mexico	40 participants	—
Sex: Female, Male Female	27 Participants	—
Sex: Female, Male Male	13 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 40	0 / 40
other Total, other adverse events	0 / 40	0 / 40
serious Total, serious adverse events	0 / 40	0 / 40

Outcome results

Primary

Corneal Coverage - Fanfilcon A Toric Lens

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

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	Yes	100 percentage of lenses
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	No	0 percentage of lenses

Primary

Corneal Coverage - Fanfilcon A Toric Lens

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

Time frame: 4-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	Yes	100 percentage of lenses
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	No	0 percentage of lenses

Primary

Corneal Coverage - Fanfilcon A Toric Lens

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

Time frame: 2-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	Yes	100 percentage of lenses
Somofilcon A Toric (Habitual)	Corneal Coverage - Fanfilcon A Toric Lens	No	0 percentage of lenses

Primary

Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

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

Time frame: 4-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Yes	100 percentage of lenses
Somofilcon A Toric (Habitual)	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	No	0 percentage of lenses

Primary

Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

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

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Yes	100 percentage of lenses
Somofilcon A Toric (Habitual)	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	No	0 percentage of lenses

Primary

Lens Centration - Fanfilcon A Toric Lens

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

Time frame: 2-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Optimum	100 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Acceptable	0 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Unacceptable	0 percentage of lenses

Primary

Lens Centration - Fanfilcon A Toric Lens

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

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Optimum	100 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Acceptable	0 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Unacceptable	0 percentage of lenses

Primary

Lens Centration - Fanfilcon A Toric Lens

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

Time frame: 4-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Optimum	100 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Acceptable	0 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Fanfilcon A Toric Lens	Unacceptable	0 percentage of lenses

Primary

Lens Centration - Somofilcon A Toric (Habitual) Lens

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

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Optimum	100 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Acceptable	0 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Unacceptable	0 percentage of lenses

Primary

Lens Centration - Somofilcon A Toric (Habitual) Lens

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

Time frame: 4 weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Optimum	100 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Acceptable	0 percentage of lenses
Somofilcon A Toric (Habitual)	Lens Centration - Somofilcon A Toric (Habitual) Lens	Unacceptable	0 percentage of lenses

Primary