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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: somofilcon A; Device: etafilcon A

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will only be eligible for the study if:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
  5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
  6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
  7. Demonstrates an acceptable fit with the study lenses;

  8. 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:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Is an employee of the Centre for Ocular Research & Education;
  10. Has participated in the BEAGLE (EX-MKTG-104) study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: somofilcon A; Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.	Device: somofilcon A; Contact Lens; Other Names: Clariti 1-Day
Active Comparator: etafilcon A; Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.	Device: etafilcon A; Contact Lens; Other Names: 1-Day Acuvue Moist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 1
Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 3
Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 5
Lens Handling for Lens Insertion	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	1 Week
Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 1
Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 3
Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	Day 5
Lens Handling for Lens Removal	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration	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)	Baseline (after 10 minutes of lens fitting)
Lens Centration	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)	1 week
Post-blink Movement	Post-blink movement in primary gaze, in 0.1mm steps	Baseline (after 10 minutes of lens fitting)
Post-blink Movement	Post-blink movement in primary gaze, in 0.1mm steps	1 -week
Push-up Tightness	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)	Baseline (after 10 minutes of lens fitting)
Push-up Tightness	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)	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Baseline
Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	1 Day
Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Day 3
Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	Day 5
Subjective Ratings of Comfort After Lens Insertion	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).	1-Week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes