Skip to main content
OpenTrials
Completed

NCT Number: NCT03835078

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ametropia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methafilcon A contact lenses

Device

Bilateral daily wear of methafilcon A contact lenses

fanfilcon A contact lenses

Device

Bilateral daily wear of fanfilcon A contact lenses

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

Secondary outcomes

  1. Average Daily Wearing Time - Methafilcon A Contact Lenses

    Time frame: 4 weeks

    Average daily wearing time response by the subject

  2. Average Daily Wearing Time - Fanfilcon A Contact Lenses

    Time frame: 2 weeks

    Average daily wearing time response by the subject.

  3. Average Daily Wearing Time - Fanfilcon A Contact Lenses

    Time frame: 4 weeks

    Average daily wearing time response by the subject

  4. Average Comfortable Wearing Time - Methafilcon A Contact Lenses

    Time frame: 4 weeks

    Average comfortable wearing time - response by the subject

  5. Average Comfortable Wearing Time - Fanfilcon A Contact Lenses

    Time frame: 2 weeks

    Average comfortable wearing time - response by the subject

  6. Average Comfortable Wearing Time - Fanfilcon A Contact Lenses

    Time frame: 4 weeks

    Average comfortable wearing time - response by the subject

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.