Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
methalfilcon 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.
Intervention: methafilcon A contact lenses (Device)
methalfilcon 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.
Intervention: fanfilcon A contact lenses (Device)
Outcomes
Primary Outcomes
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: 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
Time Frame: 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).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Time Frame: 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
Time Frame: 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
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Time Frame: Baseline
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 - Fanfilcon A Contact Lenses
Time Frame: Baseline
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 - Fanfilcon A Contact Lenses
Time Frame: 2 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
Time Frame: Baseline
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: Baseline
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: 2 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 - Methafilcon A Contact Lenses
Time Frame: Baseline
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).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: Baseline
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).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: 2 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 - Methafilcon A Contact Lenses
Time Frame: Baseline
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).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: Baseline
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).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Time Frame: 2 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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: 2 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 Outcomes
- Average Daily Wearing Time - Methafilcon A Contact Lenses(4 weeks)
- Average Comfortable Wearing Time - Fanfilcon A Contact Lenses(4 weeks)
- Average Daily Wearing Time - Fanfilcon A Contact Lenses(4 weeks)
- Average Comfortable Wearing Time - Methafilcon A Contact Lenses(4 weeks)
- Average Daily Wearing Time - Fanfilcon A Contact Lenses(2 weeks)
- Average Comfortable Wearing Time - Fanfilcon A Contact Lenses(2 weeks)