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

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06098339
Collaborator
CORE (Other)
45
Enrollment
1
Location
2
Arms
4.9
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of two different monthly replacement lens in habitual spherical soft lens wearers.

Condition or Disease Intervention/Treatment Phase
  • Device: Lens A (fanfilcon A)
  • Device: Lens B (lotrafilcon B)
 N/A

Detailed Description

This study is 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 is approximately 3 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A, then Lens B

Participants will wear Lens A for one month and then wear 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 will wear Lens B one month and then wear 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

Outcome Measures

Primary Outcome Measures

  1. Lens Handling on Removal [Day 27]

    Participants will measure subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens will be collected in the at-home diary on Day 27.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Is at least 18 years of age and no older than 39 years, 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. Self-reports having a full eye examination in the previous two years;

  5. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

  6. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

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

It is preferred that all participants are habitual frequent replacement lens wearers.

However, if this is not possible then no more than 5 participants can be habitual daily disposable lens wearers at each site, the rest must be habitual frequent replacement lens wearers;

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

  1. Has refractive astigmatism no higher than -0.75DC in each eye;

  2. Can 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. 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 or ocular 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Insight Eye Care Waterloo Ontario Canada N2L 3S1

Sponsors and Collaborators

  • Coopervision, Inc.
  • CORE

Investigators

  • Principal Investigator: Carolyn MacNeil, Insight Eye Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT06098339
Other Study ID Numbers:
  • EX-MKTG-151
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hyperopia

Study Results

No Results Posted as of Oct 24, 2023