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Completed

NCT Number: NCT03235089

A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

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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

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

About this study

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read, fully understood and signed the information consent letter
  • Currently wears or has previously worn soft contact lenses
  • Has spectacle cylinder ≤1.00D in both eyes.
  • Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
  • Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
  • Has clear corneas and no active ocular disease
  • Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion criteria

  • Has never worn contact lenses before
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  • Has any known active ocular disease and/or infection
  • Has a monovision correction
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
  • Is aphakic
  • Has undergone corneal refractive surgery
  • Is pregnant or lactating, determined by self-report

Treatment and study plan

Test lens

Device

Daily disposable contact lens

Control lens

Device

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Primary outcomes

  1. Horizontal Lens Centration Assessed in Primary Gaze

    Time frame: Baseline

    Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

  2. Horizontal Lens Centration Assessed in Primary Gaze

    Time frame: 6-hour

    Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

  3. Vertical Lens Centration Assessed in Primary Gaze

    Time frame: Baseline

    Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

  4. Vertical Lens Centration Assessed in Primary Gaze

    Time frame: 6-hours

    Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

  5. Lens Tightness Assessed by Push-up Test

    Time frame: Baseline

    Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

  6. Lens Tightness Assessed by Push-up Test

    Time frame: 6-hours

    Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

  7. Primary Gaze Lag Assessed Observing Lens Movement in Graticule

    Time frame: Baseline

    Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

  8. Primary Gaze Lag Assessed Observing Lens Movement in Graticule

    Time frame: 6 hours

    Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

  9. Horizontal Lens Lag Assessed Observing Lens Movement in Graticule

    Time frame: Baseline

    Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

  10. Horizontal Lens Lag Assessed Observing Lens Movement in Graticule

    Time frame: 6 hours

    Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

  11. Overall Lens Fit Acceptance

    Time frame: Baseline

    Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

  12. Overall Lens Fit Acceptance

    Time frame: 6 hours

    Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

  13. Up Gaze Lag Assessed Observing Lens Movement in Graticule

    Time frame: Baseline

    Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

  14. Up Gaze Lag Assessed Observing Lens Movement in Graticule

    Time frame: 6 hours

    Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

  15. Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink

    Time frame: Baseline

    Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

  16. Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink

    Time frame: 6 hours

    Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2017
Registry last updated
Oct 14, 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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