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

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ClinicalTrials.gov Identifier: NCT03835221
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ametropia Device: methafilcon A toric contact lenses Device: fanfilcon A toric contact lenses Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Primary Purpose: Other
Official Title: Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: methalfilcon A toric contact lenses Device: methafilcon A toric contact lenses
Bilateral daily wear of methafilcon A toric contact lenses

Active Comparator: fanfilcon A toric contact lenses Device: fanfilcon A toric contact lenses
Bilateral daily wear of fanfilcon A toric contact lenses




Primary Outcome Measures :
  1. Lens centration assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    Centered (optimum) slightly decentered (decentration acceptable), or substantially decentered (decentration unacceptable)

  2. Lens centration assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Centered (optimum) slightly decentered (decentration acceptable), or substantially decentered (decentration unacceptable)

  3. Lens centration assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    Centered (optimum) slightly decentered (decentration acceptable), or substantially decentered (decentration unacceptable)

  4. Lens centration assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Centered (optimum) slightly decentered (decentration acceptable), or substantially decentered (decentration unacceptable)

  5. Lens centration assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Centered (optimum) slightly decentered (decentration acceptable), or substantially decentered (decentration unacceptable)

  6. Corneal coverage assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

  7. Corneal coverage assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

  8. Corneal coverage assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

  9. Corneal coverage assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

  10. Corneal coverage assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

  11. Post-blink movement assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    (0-5) Likert Scale 0 = Insufficient, unacceptable movement, 1 = Minimal, but acceptable movement

  12. Post-blink movement assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    (0-5) Likert Scale 0 = Insufficient, unacceptable movement, 1 = Minimal, but acceptable movement

  13. Post-blink movement assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    (0-5) Likert Scale 0 = Insufficient, unacceptable movement, 1 = Minimal, but acceptable movement

  14. Post-blink movement assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    (0-5) Likert Scale 0 = Insufficient, unacceptable movement, 1 = Minimal, but acceptable movement

  15. Post-blink movement assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    (0-5) Likert Scale 0 = Insufficient, unacceptable movement, 1 = Minimal, but acceptable movement

  16. Lens orientation in primary position of gaze assessment by the investigator - methalfilcon A toric contact lenses [ Time Frame: Baseline ]
    Amount of mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees

  17. Lens orientation in primary position of gaze assessment by the investigator - methalfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Amount of mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees

  18. Lens orientation in primary position of gaze assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    Amount of mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees

  19. Lens orientation in primary position of gaze assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Amount of mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees

  20. Lens orientation in primary position of gaze assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Amount of mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees

  21. Rotational recovery assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    Lens ability to return to its original position measured 60 seconds after manually rotating the lens 450 degrees temporally

  22. Rotational recovery assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Lens ability to return to its original position measured 60 seconds after manually rotating the lens 450 degrees temporally

  23. Rotational recovery assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    Lens ability to return to its original position measured 60 seconds after manually rotating the lens 450 degrees temporally

  24. Rotational recovery assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Lens ability to return to its original position measured 60 seconds after manually rotating the lens 450 degrees temporally

  25. Rotational recovery assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Lens ability to return to its original position measured 60 seconds after manually rotating the lens 450 degrees temporally

  26. Overall stability assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    0 - 4 Scale; 0 = very poor, 4 = excellent

  27. Overall stability assessment by the investigator - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    0 - 4 Scale; 0 = very poor, 4 = excellent

  28. Overall stability assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: Baseline ]
    0 - 4 Scale; 0 = very poor, 4 = excellent

  29. Overall stability assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    0 - 4 Scale; 0 = very poor, 4 = excellent

  30. Overall stability assessment by the investigator - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    0 - 4 Scale; 0 = very poor, 4 = excellent

  31. Overall lens fit acceptance by the investigator - methafilcon A toric contact lenses [ Time Frame: Baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

  36. Overall lens fit rating - subjective response by the subject - methafilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Scale 0-10. 0= very unstable (excessive movement) and 10=very stable (good movement)

  37. Overall lens fit rating - subjective response by the subject - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Scale 0-10. 0= very unstable (excessive movement) and 10=very stable (good movement)

  38. Overall lens fit rating - subjective response by the subject - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Scale 0-10. 0= very unstable (excessive movement) and 10=very stable (good movement)

  39. Overall lens fit rating - subjective response by the subject - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Scale 0-10. 0= very unstable (excessive movement) and 10=very stable (good movement)


Secondary Outcome Measures :
  1. Average daily wearing time response by the subject - methafilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn per day from prior visit

  2. Average daily wearing time response by the subject - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn per day from prior visit

  3. Average daily wearing time response by the subject - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn per day from prior visit

  4. Average daily wearing time response by the subject - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn per day from prior visit

  5. Average comfortable wearing time - response by the subject - methafilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn per day from prior visit

  6. Average comfortable wearing time - response by the subject - methafilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn per day from prior visit

  7. Average comfortable wearing time - response by the subject - fanfilcon A toric contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn per day from prior visit

  8. Average comfortable wearing time - response by the subject - fanfilcon A toric contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn per day from prior visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835221


Contacts
Contact: Jose A Vega, O.D., MSc., FAAO 1 925 640 2964 javega@coopervision.com

Locations
Mexico
Optometry Clinic, National Autonomous University Recruiting
Mexico City, Mexico
Contact: Ruben Velazquez, MSc FIACLE       rubenvg@unam.mx   
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Ruben Velazquez, MSc FIACLE School of Optometry, National Autonomous University

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03835221     History of Changes
Other Study ID Numbers: EX-MKTG-96
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases