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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: somofilcon A; Device: etafilcon A

• Registration Number: NCT04195893
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2019-11-24
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-02-12
• Study Completion: 2020-03-11
• Results First Submitted: 2020-07-14
• Results First Submitted QC: 2020-07-14
• Status Verified: 2020-08
• Results First Posted: 2020-08-03
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
somofilcon A	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.
etafilcon A	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.

Primary Outcome Measures

Name	Time	Method
Lens Handling for Lens Insertion	1 Week	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal	1 week	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

Secondary Outcome Measures

Name	Time	Method
Post-blink Movement	1 -week	Post-blink movement in primary gaze, in 0.1mm steps
Lens Centration	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)
Push-up Tightness	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)

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada