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

Not Applicable
Completed
Conditions
Ametropia
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
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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 Lenses4 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
NameTimeMethod
Average Daily Wearing Time - Methafilcon A Contact Lenses4 weeks

Average daily wearing time response by the subject

Average Comfortable Wearing Time - Fanfilcon A Contact Lenses4 weeks

Average comfortable wearing time - response by the subject

Average Daily Wearing Time - Fanfilcon A Contact Lenses4 weeks

Average daily wearing time response by the subject

Average Comfortable Wearing Time - Methafilcon A Contact Lenses4 weeks

Average comfortable wearing time - response by the subject

Trial Locations

Locations (1)

Optometry Clinic, National Autonomous University

🇲🇽

Mexico City, Mexico

Optometry Clinic, National Autonomous University
🇲🇽Mexico City, Mexico

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