Skip to main content
OpenTrials
Completed

NCT Number: NCT02555098

A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Eye Care Center

Campbell, California, 95008, United States

About this study

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A person is eligible for inclusion in the study if they:
  • Are at least 18 years of age and have full legal capacity to volunteer;
  • Have read and signed an information consent letter;
  • Are willing and able to follow instructions and maintain the appointment schedule;
  • Are an adapted soft contact lens wearer;
  • Require spectacle lens powers in both eyes;
  • Sphere: between -1.75 to -6.00 diopters and
  • Astigmatism: between -1.00 to -2.25 and
  • Axis: 180 ± 20 degrees
  • Are willing to wear contact lenses in both eyes;
  • Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) 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 including toric orientation as acceptable.

Exclusion criteria

  • A person will be excluded from the study if they:
  • Are participating in any concurrent clinical or research study;
  • Have any known active* ocular disease and/or infection;
  • Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Are aphakic;
  • Have undergone refractive error surgery;

Treatment and study plan

Sapphire contact lenses

Device

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Senofilcon A contact lenses

Device

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Primary outcomes

  1. Subjective Ratings for Comfort

    Time frame: Baseline (10 minutes post lens settling)

    Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

  2. Subjective Ratings for Comfort

    Time frame: 2 weeks

    Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

  3. Subjective Ratings for Comfort Preference

    Time frame: Baseline (10 minutes post lens settling)

    Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

  4. Subjective Ratings for Comfort Preference

    Time frame: 2 weeks

    Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

  5. Subjective Assessment of Visual Quality

    Time frame: Baseline (10 minutes post lens settling)

    Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

  6. Subjective Assessment of Visual Quality

    Time frame: 2 weeks

    Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

  7. Subjective Assessment of Overall Satisfaction

    Time frame: Baseline (10 minutes post lens settling)

    Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

  8. Subjective Assessment of Overall Satisfaction

    Time frame: 2 weeks

    Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

  9. Subjective Overall Preference

    Time frame: Baseline (10 minutes post lens settling)

    Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

  10. Subjective Overall Preference

    Time frame: 2 weeks

    Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2015
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.