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

CooperVision, Inc.40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Astigmatism

Interventions

somofilcon A toric contact lensDEVICE

Contact Lens

fanfilcon A toric contact lensDEVICE

Contact Lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Outcomes

Primary Outcomes

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

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

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

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

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

Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

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

Time frame: Baseline

Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

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

Time frame: 4-weeks

Corneal Coverage - Fanfilcon A Toric Lens

Data from ClinicalTrials.gov

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

Time frame: Baseline

Corneal Coverage - Fanfilcon A Toric Lens

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

Time frame: 2-weeks

Corneal Coverage - Fanfilcon A Toric Lens

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

Time frame: 4-weeks

Post-Blink Movement - Somofilcon A Toric (Habitual) Lens

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

Post-Blink Movement - Somofilcon A Toric (Habitual) Lens

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

Post-Blink Movement - Fanfilcon A Toric Lens

Time frame: Baseline

Post-Blink Movement - Fanfilcon A Toric Lens

Time frame: 2-weeks

Post-Blink Movement - Fanfilcon A Toric Lens

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

Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens