Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)

Detailed Description

This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3S1
      • Insight Eye Care
• United States
  • Florida
    • Ocoee, Florida, United States, 34761
      • Coan Eye Care
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Self-reported having had a full eye examination in the previous two years;
5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;

7. Habitually wore spherical soft contact lenses, for the past 3 months minimum:

   It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

   - For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;

8. Had refractive astigmatism no higher than -0.75DC in each eye;
9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A, then Lens B; Participants wore Lens A for one month and then Lens B for one month.	Device: Lens A (fanfilcon A); Daily wear for one month; Device: Lens B (lotrafilcon B); Daily wear for one month
Experimental: Lens B, then Lens A; Participants wore Lens B one month and then Lens A for one month.	Device: Lens A (fanfilcon A); Daily wear for one month; Device: Lens B (lotrafilcon B); Daily wear for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling on Removal	Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.	Day 27

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Carolyn MacNeil, Insight Eye Care; Principal Investigator: Abigail Gillogly-Harsch, Nittany Eye Associates; Principal Investigator: Roxanne Achong-Coan, Coan Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: EX-MKTG-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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