Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Control lenses; Device: Test lenses

Detailed Description

This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ocoee, Florida, United States, 34761
      • Coan Eyecare
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group PLLC
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Pennsylvania
    • College, Pennsylvania, United States, 16801
      • Nittany Eye Associates

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 (powers +4.00 to -6.00DS)

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
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 contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Lens; All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.	Device: Control lenses; Control Multifocal lenses; Device: Test lenses; Test Multifocal lenses
Experimental: Test Lens; After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.	Device: Control lenses; Control Multifocal lenses; Device: Test lenses; Test Multifocal lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort on Insertion	Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).	Day 1 after Lens Dispense Visit

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Study Director: Lyndon Jones, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-119

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