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

Not Applicable

Completed

Conditions: Myopia

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

Registration Number: NCT03974802

Lead Sponsor: Coopervision, Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	4-weeks	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)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	4-Weeks	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)
Lens Centration for Somofilcon A (Habitual) Lens	4- weeks	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Post-Blink Movement for Fanfilcon A (Test) Lens	4-weeks	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Lens Centration for Fanfilcon A (Test) Lens	4- weeks	Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Corneal Coverage for Somofilcon A (Habitual) Lens	4 -weeks	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Post-Blink Movement for Somofilcon A (Habitual) Lens	4-weeks	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	4-Weeks	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)
Lens Corneal Coverage for Fanfilcon A (Test) Lens	4-weeks	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	4-weeks	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)

Secondary Outcome Measures

Name	Time	Method
Average Daily Wearing Time - Fanfilcon A (Test) Lens	4-weeks	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Average Daily Wearing Time - Somofilcon A (Habitual) Lens	4-weeks	Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	4 weeks	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.
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens	4 weeks	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.