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OpenTrials
Completed

NCT Number: NCT03519932

Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

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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

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 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

  • 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 PIANO (i.e. EX-MKTG-83) Study.

Treatment and study plan

comfilcon A toric lens

Device

Contact lens

Other names: Biofinity toric, test lens

samfilcon A toric lens

Device

Contact lens

Other names: Ultra for Astigmatism, control lens

Primary outcomes

  1. Comfort at Insertion

    Time frame: Dispense

    Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  2. Comfort

    Time frame: 2 weeks

    Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  3. Comfort

    Time frame: 1-month

    Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  4. Lens Preference Based on Overall Comfort

    Time frame: 1 month

    Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

  5. Lens Preference Based on Overall Dryness

    Time frame: 1 month

    Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

  6. Dryness

    Time frame: 2 weeks

    Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

  7. Dryness

    Time frame: 1-month

    Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

Secondary outcomes

  1. Ease of Insertion

    Time frame: Dispense

    Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

  2. Ease of Insertion

    Time frame: 2-weeks

    Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

  3. Ease of Insertion

    Time frame: 1-month

    Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

  4. Ease of Removal

    Time frame: 2-weeks

    Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

  5. Ease of Removal

    Time frame: 1 month

    Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 9, 2018
Registry last updated
Jan 6, 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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