Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Study Overview

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

Detailed Description

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 54090
    • 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 contact lens wearer
• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
• Have no less than -0.75D of astigmatism 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 of ≥ 1.00D 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: Treatment
• 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 (habitual) lens, then fanfilcon A (test) lens; Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.	Device: somofilcon A contact lens; Contact Lens; Other Names: Habitual lens; clariti elite; Device: fanfilcon A contact lens; Contact Lens; Other Names: Avaira Vitality; Test lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration for Somofilcon A (Habitual) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Lens Centration for Somofilcon A (Habitual) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4- weeks
Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2-weeks
Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4- weeks
Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4 -weeks
Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	2-weeks
Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4-weeks
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	Baseline
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	4-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	Baseline
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	2-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	4-Weeks
Post-Blink Movement for Somofilcon A (Habitual) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	Baseline
Post-Blink Movement for Somofilcon A (Habitual) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	4-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	Baseline
Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	2-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	4-weeks
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens	Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day	4-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day	2-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day	4-weeks
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens	Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	4 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	2 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	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): May 14, 2019
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-101

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