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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: somofilcon A toric contact lens; Device: fanfilcon A toric contact lens

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Optometry Clinic, National Autonomous University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration - Somofilcon A Toric (Habitual) Lens	Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Lens Centration - Somofilcon A Toric (Habitual) Lens	Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2-weeks
Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4-weeks
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4-weeks
Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	2-weeks
Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	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)	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).	4-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).	Baseline
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).	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).	4-weeks
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens	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).	Baseline
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens	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).	4-weeks
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	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).	Baseline
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	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).	2-weeks
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	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).	4-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens	Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.	4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.	2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.	4 weeks
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens	Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day	4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.	2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.	4 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Ruben Velázquez Guerrero, MSc., FIACLE, School of Optometry, National Autonomous University (UNAM), Mexico City

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): August 16, 2019
• Study Completion (Actual): October 18, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-102

Drug and device information, study documents

• 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