Clinical trial NCT04195893: Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
Official title: Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 56
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Lens Handling for Lens Insertion
timeFrame: Day 1
measure: Lens Handling for Lens Insertion
timeFrame: Day 3
measure: Lens Handling for Lens Insertion
timeFrame: Day 5
measure: Lens Handling for Lens Insertion
timeFrame: 1 Week
measure: Lens Handling for Lens Removal
timeFrame: Day 1
measure: Lens Handling for Lens Removal
timeFrame: Day 3
measure: Lens Handling for Lens Removal
timeFrame: Day 5
measure: Lens Handling for Lens Removal
timeFrame: 1 week
Secondary outcomes:
measure: Lens Centration
timeFrame: Baseline (after 10 minutes of lens fitting)
measure: Lens Centration
timeFrame: 1 week
measure: Post-blink Movement
timeFrame: Baseline (after 10 minutes of lens fitting)
measure: Post-blink Movement
timeFrame: 1 -week
measure: Push-up Tightness
timeFrame: Baseline (after 10 minutes of lens fitting)
measure: Push-up Tightness
timeFrame: 1 week
Other outcomes:
measure: Subjective Ratings of Comfort After Lens Insertion
timeFrame: Baseline
measure: Subjective Ratings of Comfort After Lens Insertion
timeFrame: 1 Day
measure: Subjective Ratings of Comfort After Lens Insertion
timeFrame: Day 3
measure: Subjective Ratings of Comfort After Lens Insertion
timeFrame: Day 5
measure: Subjective Ratings of Comfort After Lens Insertion
timeFrame: 1-Week
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lyndon Jones
role: PRINCIPAL_INVESTIGATOR
References: