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Completed

NCT Number: NCT04195893

Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

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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

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects will only be eligible for the study if:
  • Is at least 17 years of age 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;
  • Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
  • Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
  • Demonstrates an acceptable fit with the study lenses;
  • Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion criteria

  • Subjects will not be eligible to take part in the study if:
  • 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 (verbal confirmation at the screening visit);
  • Is aphakic;
  • Has undergone refractive error surgery;
  • Is an employee of the Centre for Ocular Research & Education;
  • Has participated in the BEAGLE (EX-MKTG-104) study.

Treatment and study plan

somofilcon A

Device

Contact Lens

Other names: Clariti 1-Day

etafilcon A

Device

Contact Lens

Other names: 1-Day Acuvue Moist

Primary outcomes

  1. Lens Handling for Lens Insertion

    Time frame: Day 1

    Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  2. Lens Handling for Lens Insertion

    Time frame: Day 3

    Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  3. Lens Handling for Lens Insertion

    Time frame: Day 5

    Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  4. Lens Handling for Lens Insertion

    Time frame: 1 Week

    Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  5. Lens Handling for Lens Removal

    Time frame: Day 1

    Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  6. Lens Handling for Lens Removal

    Time frame: Day 3

    Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  7. Lens Handling for Lens Removal

    Time frame: Day 5

    Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

  8. Lens Handling for Lens Removal

    Time frame: 1 week

    Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

Secondary outcomes

  1. Lens Centration

    Time frame: Baseline (after 10 minutes of lens fitting)

    Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus)

  2. Lens Centration

    Time frame: 1 week

    Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus)

  3. Post-blink Movement

    Time frame: Baseline (after 10 minutes of lens fitting)

    Post-blink movement in primary gaze, in 0.1mm steps

  4. Post-blink Movement

    Time frame: 1 -week

    Post-blink movement in primary gaze, in 0.1mm steps

  5. Push-up Tightness

    Time frame: Baseline (after 10 minutes of lens fitting)

    Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

  6. Push-up Tightness

    Time frame: 1 week

    Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

Other outcomes

  1. Subjective Ratings of Comfort After Lens Insertion

    Time frame: Baseline

    Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

  2. Subjective Ratings of Comfort After Lens Insertion

    Time frame: 1 Day

    Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

  3. Subjective Ratings of Comfort After Lens Insertion

    Time frame: Day 3

    Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

  4. Subjective Ratings of Comfort After Lens Insertion

    Time frame: Day 5

    Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

  5. Subjective Ratings of Comfort After Lens Insertion

    Time frame: 1-Week

    Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
Aug 18, 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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