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

NCT04195893 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-112
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Lens Centration

  Baseline (after 10 minutes of lens fitting)

• Lens Centration

  1 week

• Post-blink Movement

  Baseline (after 10 minutes of lens fitting)

• Post-blink Movement

  1 -week

• Push-up Tightness

  Baseline (after 10 minutes of lens fitting)

Other Outcomes (5)

• Subjective Ratings of Comfort After Lens Insertion

  Baseline

• Subjective Ratings of Comfort After Lens Insertion

  1 Day

• Subjective Ratings of Comfort After Lens Insertion

  Day 3

Study Arms (2)

somofilcon A

EXPERIMENTAL

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

etafilcon A

ACTIVE COMPARATOR

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

Interventions

somofilcon A DEVICE

Contact Lens

Also known as: Clariti 1-Day

somofilcon A

etafilcon A DEVICE

Contact Lens

Also known as: 1-Day Acuvue Moist

etafilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D, MSc., FAAO
• Organization: CooperVision. Inc

javega@coopervision.com

9256213761

Study Officials

• Lyndon Jones

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: November 24, 2019
• Primary Completion: February 12, 2020
• Study Completion: March 11, 2020
• Last Updated: August 18, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-08

Locations

CA (1)