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Completed

NCT Number: NCT03684928

A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

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 at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years.
  • 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, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
  • Is willing to wear contact lens in both eyes for the duration of the study;
  • Has a minimum astigmatism of - 0.75, determined by refraction;
  • Can be fit with the two study contact lens types in the powers available;
  • Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
  • Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
  • Has clear corneas and no active* ocular disease;

Exclusion criteria

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

  • Is participating in any concurrent clinical trial;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study measure;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
  • Has known sensitivity to fluorescein dye or products to be used in the study;
  • Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
  • 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;
  • Has participated in the previous QUENA study.

Treatment and study plan

Comfilcon A (test)

Device

Daily wear contact lenses

Senofilcon C (control)

Device

Daily wear contact lenses

Primary outcomes

  1. Ease of Insertion(Handling)

    Time frame: Baseline

    Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

  2. Ease of Insertion (Handling)

    Time frame: 2 weeks

    Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

  3. Ease of Insertion(Handling)

    Time frame: 1 month

    Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

Secondary outcomes

  1. Rotational Recovery After Lens Mislocation

    Time frame: Baseline

    Lens relocation after 10 blinks, after 30º rotation mislocation

  2. Rotational Recovery After Lens Mislocation

    Time frame: 1 month

    Lens relocation after 10 blinks, after 30º rotation mislocation.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 26, 2018
Registry last updated
Jun 26, 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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