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

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ClinicalTrials.gov Identifier: NCT03835078
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 aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Condition or disease Intervention/treatment Phase
Ametropia Device: methafilcon A contact lenses Device: fanfilcon A 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 Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
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 contact lenses Device: methafilcon A contact lenses
Bilateral daily wear of methafilcon A contact lenses

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




Primary Outcome Measures :
  1. Lens centration assessment by the investigator - methafilcon A 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 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 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 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 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 contact lenses [ Time Frame: Baseline ]
    Corneal coverage obtained (yes) or coverage not obtained (no)

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

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

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

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

  16. Lens tightness assessment by the investigator - methafilcon A contact lenses [ Time Frame: Baseline ]
    Push up test (0% to 100%); (50% optimum)

  17. Lens tightness assessment by the investigator - methafilcon A contact lenses [ Time Frame: 4 weeks ]
    Push up test (0% to 100%); (50% optimum)

  18. Lens tightness assessment by the investigator - fanfilcon A contact lenses [ Time Frame: Baseline ]
    Push up test (0% to 100%); (50% optimum)

  19. Lens tightness assessment by the investigator - fanfilcon A contact lenses [ Time Frame: 2 weeks ]
    Push up test (0% to 100%); (50% optimum)

  20. Lens tightness assessment by the investigator - fanfilcon A contact lenses [ Time Frame: 4 weeks ]
    Push up test (0% to 100%); (50% optimum)

  21. Overall lens fit acceptance by the investigator - methafilcon A 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

  22. Overall lens fit acceptance by the investigator - methafilcon A 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

  23. Overall lens fit acceptance by the investigator - fanfilcon A 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

  24. Overall lens fit acceptance by the investigator - fanfilcon A 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

  25. Overall lens fit acceptance by the investigator - fanfilcon A 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

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

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

  28. Overall lens fit rating - subjective response by the subject - fanfilcon A 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 contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn

  2. Average daily wearing time response by the subject - fanfilcon A contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn

  3. Average daily wearing time response by the subject - fanfilcon A contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn

  4. Average comfortable wearing time - response by the subject - methafilcon A contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn (0-x) per day from prior visit

  5. Average comfortable wearing time - response by the subject - fanfilcon A contact lenses [ Time Frame: 2 weeks ]
    Number of hours contact lenses worn (0-x) per day from prior visit

  6. Average comfortable wearing time - response by the subject - fanfilcon A contact lenses [ Time Frame: 4 weeks ]
    Number of hours contact lenses worn (0-x) per day from prior visit



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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 - 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

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): NCT03835078


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: NCT03835078     History of Changes
Other Study ID Numbers: EX-MKTG-98
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