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OpenTrials
Completed

NCT Number: NCT04050618

Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Optometric Group, Whittier, California, United States

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About this study

This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be a currently adapted soft contact lens wearer (>1 month of lens wear).
  • Be at least 18 years of age.
  • Refractive astigmatism <1.00D in both eyes.
  • Have clear corneas and be free of any anterior segment disorders.
  • Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
  • Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
  • Require visual correction in both eyes (monovision allowed, no monofit).
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • No amblyopia
  • No strabismus
  • No evidence of lid abnormality or infection
  • No conjunctival abnormality or infection that would contraindicate contact lens wear
  • No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  • No other active ocular disease.
  • Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
  • Willing to comply with the wear and study visit schedule.

Exclusion criteria

  • Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55.
  • Require toric or multifocal contact lenses.
  • Previously shown a sensitivity to any of the study solution components.
  • Any systemic or ocular disease or allergies affecting ocular health.
  • Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
  • Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
  • Keratoconus or other corneal irregularity.
  • Aphakia or amblyopia.
  • Have undergone corneal refractive surgery or any anterior segment surgery.
  • Abnormal lacrimal secretions.
  • Has diabetes.
  • Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of chronic eye disease (e.g. glaucoma).
  • Pregnant or lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial or in last 30 days.

Treatment and study plan

fanfilcon A test lens

Device

Silicone hydrogel contact lens

Other names: test lens, Avaira Vitality

ocufilcon D control lens

Device

hydrogel contact lens

Other names: Biomedics 55 Premier, ocufilcon D (4-weekly) control lens

etafilcon A control lens

Device

hydrogel contact lens

Other names: etafilcon A (2-weekly) control lens, Acuvue 2

Primary outcomes

  1. Subjective Overall Comfort Rating

    Time frame: Two weeks

    Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

  2. Subjective Overall Comfort Rating

    Time frame: Four weeks

    Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Secondary outcomes

  1. Average Wearing Time

    Time frame: Two weeks

    Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

  2. Average Wearing Time

    Time frame: Four weeks

    Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

  3. Average Comfortable Wearing Time

    Time frame: Two weeks

    Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

  4. Average Comfortable Wearing Time

    Time frame: Four weeks

    Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

  5. Lens Centration

    Time frame: Baseline (after 15 minutes)

    Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).

  6. Lens Centration

    Time frame: Two weeks

    Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).

  7. Lens Centration

    Time frame: Four weeks

    Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).

  8. Corneal Coverage

    Time frame: Baseline (after 15 minutes of lens dispense)

    Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

  9. Corneal Coverage

    Time frame: Two weeks

    Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

  10. Corneal Coverage

    Time frame: Four weeks

    Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

  11. Post-Blink Movement

    Time frame: Baseline (after 15 minutes of lens dispense)

    Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  12. Post-Blink Movement

    Time frame: Two weeks

    Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  13. Post-Blink Movement

    Time frame: Four weeks

    Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  14. Lens Tightness - Push-up Test

    Time frame: Baseline (after 15 minutes of lens dispense)

    Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

  15. Lens Tightness - Push-up Test

    Time frame: Two weeks

    Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

  16. Lens Tightness - Push-up Test

    Time frame: Four weeks

    Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

  17. Overall Lens Fit Acceptance

    Time frame: Baseline (after 15 minutes of lens dispense)

    Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

  18. Overall Lens Fit Acceptance

    Time frame: Two weeks

    Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

  19. Overall Lens Fit Acceptance

    Time frame: Four weeks

    Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

  20. Rating of Lens Surface Wettability

    Time frame: Baseline (after 15 minutes of lens dispense)

    Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

  21. Rating of Lens Surface Wettability

    Time frame: Two weeks

    Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

  22. Rating of Lens Surface Wettability

    Time frame: Four weeks

    Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

  23. Presence of Film Deposits

    Time frame: Two weeks

    Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).

  24. Presence of Film Deposits

    Time frame: Four weeks

    Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).

  25. Number of White Spot Deposits

    Time frame: Two weeks

    Number of white spot deposits assessed using slit lamp with white light, low medium magnification

  26. Number of White Spot Deposits

    Time frame: Four weeks

    Number of white spot deposits assessed using slit lamp with white light, low medium magnification

  27. Primary Gaze Lag

    Time frame: Baseline (after 15 minutes of lens dispense)

    Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  28. Primary Gaze Lag

    Time frame: Two weeks

    Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  29. Primary Gaze Lag

    Time frame: Four weeks

    Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

  30. Comfort Throughout the Day

    Time frame: Day 3 - 8:00am

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  31. Comfort Throughout the Day

    Time frame: Day 3 - 12:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  32. Comfort Throughout the Day

    Time frame: Day 3 - 4:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  33. Comfort Throughout the Day

    Time frame: Day 3 - 8:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  34. Comfort Throughout the Day

    Time frame: Day 7 - 8:00am

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  35. Comfort Throughout the Day

    Time frame: Day 7 - 12:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  36. Comfort Throughout the Day

    Time frame: Day 7 - 4:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  37. Comfort Throughout the Day

    Time frame: Day 7 - 8:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  38. Comfort Throughout the Day

    Time frame: Day 12 - 8:00am

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  39. Comfort Throughout the Day

    Time frame: Day 12 - 12:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  40. Comfort Throughout the Day

    Time frame: Day 12 - 4:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  41. Comfort Throughout the Day

    Time frame: Day 12 - 8:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  42. Comfort Throughout the Day

    Time frame: Day 26 - 8:00am

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  43. Comfort Throughout the Day

    Time frame: Day 26 - 12:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  44. Comfort Throughout the Day

    Time frame: Day 26 - 4:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

  45. Comfort Throughout the Day

    Time frame: Day 26 - 8:00pm

    Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Oct 19, 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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