Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Not Applicable

Completed

Conditions: Ametropia

Interventions: Device: methafilcon A contact lenses
Device: fanfilcon A contact lenses

Registration Number: NCT03835078

Lead Sponsor: Coopervision, Inc.

Brief Summary: The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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 (Diopter) 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
Has a history of not achieving comfortable Contact Lens (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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
methalfilcon A contact lenses / fanfilcon A contact lenses	methafilcon A contact lenses	All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.
methalfilcon A contact lenses / fanfilcon A contact lenses	fanfilcon A contact lenses	All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	4 weeks	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	4 weeks	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	4 weeks	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	4 weeks	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	4 weeks	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	4 weeks	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	4 weeks	Post-blink movement, was rated at each visit using a 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 Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	4 weeks	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	4 weeks	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	4 weeks	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Secondary Outcome Measures

Name	Time	Method
Average Daily Wearing Time - Methafilcon A Contact Lenses	4 weeks	Average daily wearing time response by the subject
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject
Average Daily Wearing Time - Fanfilcon A Contact Lenses	4 weeks	Average daily wearing time response by the subject
Average Comfortable Wearing Time - Methafilcon A Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject