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Completed

NCT Number: NCT02727816

Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

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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, Mexico

About this study

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • 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 CL (Contact Lens) wearer.
  • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
  • 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.
  • Is willing to comply with the visit schedule.

Exclusion criteria

A person will be excluded from the study if he/she:

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a CL prescription outside the range of - 1.00 to - 6.00D
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • 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 (GPC) 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

filcon IV I (BC 8.6)

Device

control lens

filcon IV I (BC 8.7)

Device

control lens

ocufilcon D

Device

test lens

methafilcon A (BC 8.6)

Device

control lens

methafilcon A (BC 8.7)

Device

control lens

somofilcon A

Device

test lens

Primary outcomes

  1. Centration - Pair One

    Time frame: Baseline and 1 hour

    Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).

  2. Centration - Pair Two

    Time frame: Baseline and 1 hour

    Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).

  3. Centration - Pair Three

    Time frame: Baseline and 1 hour

    Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).

  4. Centration - Pair Four

    Time frame: Baseline and 1 hour

    Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).

  5. Post-blink Movement - Pair One

    Time frame: Baseline

    Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  6. Post-blink Movement - Pair One

    Time frame: 1 hour

    Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  7. Post-blink Movement - Pair Two

    Time frame: Baseline

    Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  8. Post-blink Movement - Pair Two

    Time frame: 1 hour

    Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  9. Post-blink Movement - Pair Three

    Time frame: Baseline

    Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  10. Post-blink Movement - Pair Three

    Time frame: 1 hour

    Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  11. Post-blink Movement - Pair Four

    Time frame: Baseline

    Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  12. Post-blink Movement - Pair Four

    Time frame: 1 hour

    Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

  13. Lens Tightness - Pair One

    Time frame: Baseline and 1 hour

    Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

  14. Lens Tightness - Pair Two

    Time frame: Baseline and 1 hour

    Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

  15. Lens Tightness - Pair Three

    Time frame: Baseline and 1 hour

    Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

  16. Lens Tightness - Pair Four

    Time frame: Baseline and 1 hour

    Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

  17. Overall Fit Preference - Pair One

    Time frame: Baseline and 1 hour

    Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.

  18. Overall Fit Acceptance - Pair Two

    Time frame: Baseline and 1 hour

    Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.

  19. Overall Fit Acceptance - Pair Three

    Time frame: Baseline and 1 hour

    Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.

  20. Overall Fit Acceptance - Pair Four

    Time frame: Baseline and 1 hour

    Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Feb 6, 2018

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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