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OpenTrials
Completed

NCT Number: NCT03974802

Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

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Key information

Conditions

Myopia 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, 54090, Mexico

About this study

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

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 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 CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder of ≥ 1.00D in either eye.
  • Has a history of not achieving comfortable 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

somofilcon A contact lens

Device

Contact Lens

Other names: clariti elite, Habitual lens

fanfilcon A contact lens

Device

Contact Lens

Other names: Avaira Vitality, Test lens

Primary outcomes

  1. Lens Centration for Somofilcon A (Habitual) Lens

    Time frame: Baseline

    Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  2. Lens Centration for Somofilcon A (Habitual) Lens

    Time frame: 4- weeks

    Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  3. Lens Centration for Fanfilcon A (Test) Lens

    Time frame: Baseline

    Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4. Lens Centration for Fanfilcon A (Test) Lens

    Time frame: 2-weeks

    Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  5. Lens Centration for Fanfilcon A (Test) Lens

    Time frame: 4- weeks

    Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  6. Lens Corneal Coverage for Somofilcon A (Habitual) Lens

    Time frame: Baseline

    Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  7. Lens Corneal Coverage for Somofilcon A (Habitual) Lens

    Time frame: 4 -weeks

    Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  8. Lens Corneal Coverage for Fanfilcon A (Test) Lens

    Time frame: Baseline

    Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  9. Lens Corneal Coverage for Fanfilcon A (Test) Lens

    Time frame: 2-weeks

    Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  10. Lens Corneal Coverage for Fanfilcon A (Test) Lens

    Time frame: 4-weeks

    Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  11. Percentage of Lens Tightness for Somofilcon A (Habitual) Lens

    Time frame: Baseline

    Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  12. Percentage of Lens Tightness for Somofilcon A (Habitual) Lens

    Time frame: 4-Weeks

    Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  13. Percentage of Lens Tightness for Fanfilcon A (Test) Lens

    Time frame: Baseline

    Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  14. Percentage of Lens Tightness for Fanfilcon A (Test) Lens

    Time frame: 2-Weeks

    Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  15. Percentage of Lens Tightness for Fanfilcon A (Test) Lens

    Time frame: 4-Weeks

    Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  16. Post-Blink Movement for Somofilcon A (Habitual) Lens

    Time frame: Baseline

    Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  17. Post-Blink Movement for Somofilcon A (Habitual) Lens

    Time frame: 4-weeks

    Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  18. Post-Blink Movement for Fanfilcon A (Test) Lens

    Time frame: Baseline

    Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  19. Post-Blink Movement for Fanfilcon A (Test) Lens

    Time frame: 2-weeks

    Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  20. Post-Blink Movement for Fanfilcon A (Test) Lens

    Time frame: 4-weeks

    Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  21. Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

    Time frame: Baseline

    Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  22. Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

    Time frame: 4-weeks

    Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  23. Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

    Time frame: Baseline

    Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  24. Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

    Time frame: 2-weeks

    Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  25. Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

    Time frame: 4-weeks

    Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Secondary outcomes

  1. Average Daily Wearing Time - Somofilcon A (Habitual) Lens

    Time frame: 4-weeks

    Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day

  2. Average Daily Wearing Time - Fanfilcon A (Test) Lens

    Time frame: 2-weeks

    Average daily wearing time for fanfilcon A (test) lens was measured in hours/day

  3. Average Daily Wearing Time - Fanfilcon A (Test) Lens

    Time frame: 4-weeks

    Average daily wearing time for fanfilcon A (test) lens was measured in hours/day

  4. Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens

    Time frame: 4 weeks

    Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

  5. Average Comfortable Wearing Time - Fanfilcon A (Test) Lens

    Time frame: 2 weeks

    Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

  6. Average Comfortable Wearing Time - Fanfilcon A (Test) Lens

    Time frame: 4 weeks

    Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2019
Registry last updated
Aug 18, 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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