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Completed

NCT Number: NCT03835221

Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

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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 +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 D 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 less than -0.75D or more than -2.50 D of cylinder 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
  • 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.

Treatment and study plan

methafilcon A toric contact lenses

Device

Bilateral daily wear of methafilcon A toric contact lenses

fanfilcon A toric contact lenses

Device

Bilateral daily wear of fanfilcon A toric contact lenses

Primary outcomes

  1. Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  2. Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  3. Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4. Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  5. Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens centration was assessed on a 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 Toric Contact Lenses

    Time frame: Baseline

    Corneal coverage was 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 Toric Contact Lenses

    Time frame: 4 weeks

    Corneal coverage was 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 Toric Contact Lenses

    Time frame: Baseline

    Corneal coverage was 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 Toric Contact Lenses

    Time frame: 2 weeks

    Corneal coverage was 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 Toric Contact Lenses

    Time frame: 4 weeks

    Corneal coverage was 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 Toric Contact Lenses

    Time frame: Baseline

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses

    Time frame: 4 weeks

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses

    Time frame: Baseline

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses

    Time frame: 2 weeks

    Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses

    Time frame: 4 weeks

    Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  16. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

  17. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

  18. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

  19. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

  20. Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

  21. Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

  22. Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

  23. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: Baseline

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

  24. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

  25. Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

  26. Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: Baseline

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

  27. Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

  28. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: Baseline

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

  29. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

  30. Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

  31. Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: Baseline

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

  32. Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

  33. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: Baseline

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

  34. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

  35. Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses

    Time frame: 4 weeks

    Average daily wearing time response by the subject

  2. Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Average daily wearing time response by the subject

  3. Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Average daily wearing time response by the subject

  4. Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses

    Time frame: 4 weeks

    Average comfortable wearing time - response by the subject

  5. Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses

    Time frame: 2 weeks

    Average comfortable wearing time - response by the subject

  6. Average Comfortable Wearing Time - Fanfilcon A Toric 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.

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