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Completed

NCT Number: NCT02345811

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Contact Lens Research, University of Waterloo, Waterloo, Ontario, Canada

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About this study

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
  • Has read and signed an information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer
  • Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
  • Has no more than 0.75 diopters of refractive astigmatism
  • Willing to wear contact lens in both eyes
  • Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
  • To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Exclusion criteria

  • Is participating in any concurrent clinical or research study
  • Has any known active* ocular disease and/or infection
  • 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
  • Is aphakic
  • Has undergone refractive error surgery

Treatment and study plan

Sapphire

Device

silicone-hydrogel contact lens

Senofilcon A

Device

contact lens

Primary outcomes

  1. Vision Quality

    Time frame: Baseline (10 minutes post lens settling at dispense)

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

  2. Vision Quality

    Time frame: 2 weeks - During the Day

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

  3. Vision Quality

    Time frame: 2 weeks - End of Day

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

  4. Subjective Rating for Comfort.

    Time frame: Baseline - 10 minutes post lens settling

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

  5. Subjective Rating for Comfort.

    Time frame: 2-weeks - During the Day

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

  6. Subjective Rating for Comfort.

    Time frame: 2-weeks - End of Day

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

  7. Lens Surface Wettability

    Time frame: Baseline (10 minutes post lens settling)

    Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

  8. Lens Surface Wettability

    Time frame: 2 weeks

    Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

  9. Surface Deposits

    Time frame: Baseline (10 minutes post lens settling)

    Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)

  10. Surface Deposits

    Time frame: 2-weeks

    Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)

  11. Lens Handling (Ease of Insertion)

    Time frame: 2 weeks

    Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.

  12. Lens Handling (Ease of Removal)

    Time frame: 2 weeks

    Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.

  13. Subjective Preference for Comfort.

    Time frame: Baseline - 10 minutes post lens settling

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

  14. Subjective Preference for Comfort.

    Time frame: 2 weeks

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Sep 16, 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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