Comparing the Performance of 1 Day Multifocal Contact Lenses

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens A; Device: Lens B; Device: Habitual Lenses

Detailed Description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • Scripps Poway Eyecare
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Florida
    • Sarasota, Florida, United States, 34237
      • Golden Vision
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
7. Has refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Habitually wears one of the study contact lenses;
3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
8. Has undergone refractive error surgery or intraocular surgery.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A (Test); Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Lens A; Subjects will be randomized to wear Lens A (test) for 2 weeks.; Other Names: FDA Approved, non-marketed, daily disposable multifocal lens; Device: Lens B; Subjects will be randomized to wear Lens B (control) for 2 weeks.; Other Names: FDA Approved, daily disposable multifocal lens; Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Lens B (Control); Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Lens A; Subjects will be randomized to wear Lens A (test) for 2 weeks.; Other Names: FDA Approved, non-marketed, daily disposable multifocal lens; Device: Lens B; Subjects will be randomized to wear Lens B (control) for 2 weeks.; Other Names: FDA Approved, daily disposable multifocal lens; Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Habitual Lenses; All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.	Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective At-home Ratings for Ease of Lens Handling for Insertion	Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)	Day 13

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Wayne Golden, Golden Vision; Principal Investigator: Keith Wan, Scripps Poway Eyecare; Principal Investigator: Shane Kannarr, Kannarr Eye Care; Principal Investigator: David Ardaya, Golden Optometric Group

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-109

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